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URGENT: Field Notice

Type of Action:

Correction

Stryker Reference:

RA2009-124

Product Description:

SDC HD (Digital Image Capture System)

Product reference:

0240050888 and 0240050888i

Lot /Serial reference:

All devices since the launch of SDC HD (2004) are affected

Dear Customer
Our manufacturer, Stryker Endoscopy, has notified us of a Product Field Action concerning
the Medical Devices referenced above. Our records indicate that your organisation has been
supplied with some of the subject devices. We would request therefore that you read this
notice carefully and follow the instructions provided by the manufacturer.
We would like to reassure you that only the devices listed are affected by this action.
Description of the problem:
The SDC HD picture/video device will not be able to assign the correct time/date stamp for
saved files after 31 December 2009. On 1 Jan 2010, the system date for all SDC HD units
will re-start from 1 Oct 2001 and begin incrementing from that point onwards.
Potential Hazards associated with use of device
1. SDC system has incorrect date after 1 Jan 2010
2. New cases archived after 1 Jan 2010 using the SDC system have incorrect date
stamps.

RA2009-124 Customer Notification FSN V0

Immediate Actions:
1.
Immediately locate all subject devices within your organisation.
2.
Circulate this notification to all interested/affected parties and maintain awareness of
this notice internally until all required actions have been completed within your
organisation.
3.
Immediately inform Stryker of any adverse events concerning use/attempted use of
subject devices.
4.
Inform Stryker if any of the subject devices have been distributed to other
organisations. Please provide contact details so that Stryker can inform the recipients
appropriately.
5.
Complete and sign the attached customer response form on page 3.
(Please complete this form even if you do not have any affected product. This will
preclude the need for Stryker to send any reminder notices.)
6.
Return the completed form, contact details given below:
On receipt of the completed customer response form you will be contacted by a Stryker
representative who will arrange for a Stryker engineer to visit your organisation to
upgrade the affected device(s).
On behalf of Stryker I would like to thank you sincerely for your cooperation in this matter.
Should you require any further information or have any queries on the matter please do not
hesitate to contact the undersigned on XXXXX
Yours faithfully,

RA2009-124 Customer Notification FSN V0

CUSTOMER RESPONSE FORM


Regulatory Action#:

RA 2009-124

Description:

SDC HD

Product Reference:

0240050888

Lot Reference:

All

PLEASE TICK APPROPRIATE SECTION

WE HAVE PHYSICALLY CHECKED ALL HOSPITAL LOCATIONS, AND WE DO


NOT HAVE THE AFFECTED PRODUCT.

WE HAVE LOCATED THE AFFECTED PRODUCT REFERENCED IN THE


ENCLOSED LETTER. PLEASE ARRANGE FOR AN ENGINEER TO VISIT OUR
ORGANISATION TO UPGRADE THE FOLLOWING PRODUCT:

PRODUCT REFERENCE

LOT/SERIAL REFERENCE

Please sign and return this form to acknowledge receipt of product notice.
Name of Hospital/
Address
Organisation
Contact Name
Contact Title
Contact Signature
Contact Phone No.
Date

PLEASE COMPLETE AND FAX THIS FORM TO _______________


OR EMAIL TO ___________________________

RA2009-124 Customer Notification FSN V0

RA2009-124: Field Notice

We wrote to you, on xxx, notifying you of a Product Field Action.


In this notification we explained that a problem had been identified with the date mechanism on
our SDC HD units and that all units in the field would require a software update in order to rectify
this.
The purpose of this notice is to provide you with additional information regarding this Product
Field Action. We request that you read this notice carefully and follow the instructions provided.
Description of the problem:
The SDC HD picture/video device will not be able to assign the correct time/date stamp for
saved files after 31 December 2009. On 1 Jan 2010, the system date for all SDC HD units
will re-start from 1 Oct 2001 and begin incrementing from that point onwards.
Potential Hazards associated with use of the device after 31 December 2009.
1. SDC system has incorrect date from 1 Jan 2010
a. During installation/setup of the SDC HD the user becomes aware that they
cannot set a date beyond 31 Dec 2009. There may be a minor delay to
procedure/treatment with negligible or no harm to the patient.
2. New cases archived from 1 Jan 2010 using the SDC system have incorrect date
stamps.
a. The user has difficulty identifying which archived case was performed at what
time due to an incorrect date-time stamp. There may be a minor delay to
procedure/treatment with negligible or no harm to the patient.
b. SDC needs to be rebooted to reset the system which may cause a delay for up to
5 minutes to the procedure/ treatment with negligible or no harm to the patient.
c. The user will notice an old case from over 8 years ago is overwritten. This will
only occur in the very rare instance when a case is saved to the exact date, time,
minute, and second of the original case. There is no harm to patient as harm to
patient is mitigated by access to hospital records.
d. Potential patient injury due to the unnecessary initiation of a surgical procedure:
due to user accessing a recent case with an incorrect date-time stamp. Although
the SDC is not intended for diagnosis purposes, there is a remote possibility of
medical or surgical intervention. Risk mitigation includes access to hospital
records.
We note that as of today we have not received a Customer Response Form from you and there
may still be units within your facility which have not been upgraded. The software upgrade
process is a relatively simple process. We have included a complete upgrade package to allow
you to complete this upgrade and therefore continue to use the units without interruption. This
includes:

Instructions for upgrade


A CD and/or dongle

We request that you:

Ensure that a back-up is taken of the hard drive prior to installation of the
new software.

RA2009-124 Customer Notification FSN Reminder Letter V0

That a test is performed after installation to ensure that the unit performs as
intended.

We would like to reassure you that, pending completion of the software upgrade, there are no
issues with continuing to use these devices up until the 31 December 2009. However we
request that you read the following instructions carefully and then complete the attached
customer response form to acknowledge.

1. Immediately locate all subject devices.


2. Complete the new software installation, as detailed in the enclosed work
instructions.
a. Should you prefer a Stryker Technician to perform the necessary
upgrade then please indicate this on the customer response form.
We will then contact you to arrange an appointment.
3. For units pending upgrade: ensure that devices are labelled 'Do not use
after 31 DECEMBER 2009' unless upgraded in line with manufacturer
instructions provided in bulletin RA2009-124.
4. For units pending upgrade: ensure that a process is put in place to
physically remove from service and quarantine all units which have not
been upgraded appropriately by the 31 DECEMBER 2009.
5. Complete the Customer Acknowledgement Form and return to local
Stryker Distribution site or Stryker Authorised Dealer
6. Ensure that copies of this FSN are circulated internally to all affected
users.
7. Display the notice prominently until all required actions have been
completed within the facility.
8. Immediately inform Stryker of any adverse events concerning
use/attempted use of subject devices.
9. Inform Stryker if any of the subject devices have been distributed to other
organisations. Please provide contact details so that Stryker can inform
the recipients appropriately.
10. Comply with any national regulations concerning notification of adverse
events to National Regulatory Bodies.
On behalf of Stryker I would like to thank you sincerely for your help and support
in ensuring that these units are upgraded appropriately.
Yours .

RA2009-124 Customer Notification FSN Reminder Letter V0

Stryker SDC HD Urgent Device Correction Page 1 of 4

Requirements:
a. SDCHD
b. Powercord
c. SDCHDdonglesoftwarefix
SDCHDrestoreCD

Instructions:

1. DisconnectallcablesfromtheSDCHDexceptthepowercord.
2. PowerontheSDCHD.
3. SelectCONFIGtocheckwhichsoftwareversionisinstalled.
Ifversion3.0.2.3isinstalledonyourunit,pleaseusetheSDCHDdonglesoftwarefix.
Forallotherversions,pleaseusetheSDCHDrestoreCD.

Ifversion3.0.2.3isinstalled:

LoadtheSDCHDdongleintotheUSBportoftheSDCHD.
1. 1.
LoadtheSDCHDdongleintotheUSBportoftheSDCHD.

2.SelectSAVE
buttonand
Installationwill
start.

Stryker SDC HD Urgent Device Correction Page 2 of 4

3.Installationwill

proceedautomatically

YoumayseeerrormessageG:\Setup.sgncontainsaninvalidpath.
YoumayseeerrormessageG:\Setup.sgncontainsaninvalidpath.
Ifyouseethefollowingmessage,theusermayclickokordisregard.
Ifyouseethefollowingmessage,theusermayclickokordisregard.
Installationwillproceedautomatically.

Stryker SDC HD Urgent Device Correction Page 3 of 4

4.SelectNEXTon
prompts.

Stryker SDC HD Urgent Device Correction Page 4 of 4

5.Systemwill

reboot

automatically.

IfanyotherSDCHDsoftwareversionisinstalled(anyversionotherthan3.0):

1. InserttheSDCHDrestoreCDintotheCDROMdrive.
2. Installationwillproceedautomatically.
3. Systemwillrebootautomatically.

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