|
Catalog Number QD11 |
Device Problem
Defective Component (2292)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/08/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Udi (b)(4).Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the bearing of the attachment device was failing.It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the locking components of the attachment device were damaged.It was noted that the thimble screw was loose.It was further determined that the device failed pretest for check thimble screw set.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|