SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
|
Back to Search Results |
|
Catalog Number 511.801 |
Device Problems
Complete Loss of Power (4015); Excessive Heating (4030)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/06/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was traced to component failure due to normal wear.Udi: (b)(4).(b)(6).
|
|
Event Description
|
It was reported from (b)(6) that during service and evaluation, it was determined that the oscillating saw attachment device had cosmetic damage, component damage, the etching was illegible, made excessive noise, overheated and did not function.It was further determined that the device failed pretest for general condition, marking & labeling, check symmetry with handpiece and check function in running mode.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.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.
|
|
Search Alerts/Recalls
|
|
|