|
Catalog Number QD8 |
Device Problems
Break (1069); Defective Device (2588); Device Operates Differently Than Expected (2913); Naturally Worn (2988)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
It was reported from (b)(6) that during service and evaluation, it was observed that the housing was damaged and defective (totally eroded and the serial number was unreadable) on the attachment device.It was further determined that the device failed the following pre-tests: visual assessment, thimble set screw and temperature assessment.It was noted in the service order that the etching was worn away on the device.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|