|
Catalog Number 530.610 |
Device Problems
Power Conditioning Problem (1474); Mechanical Jam (2983); Naturally Worn (2988); Output below Specifications (3004); Positioning Problem (3009); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(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 confirmed.It was further determined that the motor was defective.The assignable root cause was determined to be due to improper cleaning and maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Event Description
|
It was reported by (b)(6) that during service and evaluation, it was discovered that the motor seized, blocked and was running rough on the battery oscillator device.It was further determined that the motor had dropouts, the cable of the control was opened, and the saw head housing was worn.It was further determined that the trigger was sluggish and the device was dirty.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
|
|
|