SYNTHES GMBH COLIBRI II HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
|
Back to Search Results |
|
Catalog Number 532.101 |
Device Problems
Detachment of Device or Device Component (2907); Mechanical Jam (2983); Complete Loss of Power (4015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition of the device falling apart and being unattached was confirmed.The assignable root cause was determined to be due to component failure from wear.(b)(4).
|
|
Event Description
|
It was reported by (b)(6) that during service and evaluation, it was determined that the power of the small battery drive device was insufficient/low, and the coupling lever was broken and was out.It was further observed that the device fell apart and was unattached and it had a component damage.It was further determined that the device failed pretest for general condition, check the attachment coupling and check power with power test bench.It was noted in the service order that the device did not work anymore.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 the event was unknown.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|