|
Catalog Number QD11 |
Device Problem
Defective Component (2292)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/18/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(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 discovered that the bearing was failing on the motor device.It was reported that the event occurred during use on a patient.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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 reported condition was confirmed.It was determined that the bearings/corrosion was damaged.It was further determined that the device failed pretest for temperature assessment, cutter insertion and thimble lock operation.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|