SMITH & NEPHEW, INC. LIGHT SOURCE LED 3000; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
|
Back to Search Results |
|
Catalog Number 72204011 |
Device Problem
Optical Obstruction (3002)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/16/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that during a routine inspection the light source was switching on, but there is no light output.No case was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Manufacturer Narrative
|
H10, h3, h6: the reported device, intended for use in treatment was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Reassessment found that the alleged device is not a smith+nephew product.As a result, smith+nephew is not responsible for reporting according to 21 c.F.R.Part 803.3.Additionally, manufacturer has been notified of the event.If further details are provided confirming there is a sn product involved in the event, our files will be updated and the event will be reassessed accordingly.
|
|
Search Alerts/Recalls
|
|
|