|
Catalog Number 05.001.201 |
Device Problems
Mechanical Jam (2983); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2020 |
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 device¿s oscillating function not working was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition of sticky trigger was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
|
|
Event Description
|
It was reported by (b)(6) that during service and evaluation, it was determined that the trigger of the battery handpiece/modular device was sticky, and the device had a leak tightness test failure and a component damage.It was further determined that the housing was deformed/bent.It was further determined that the device failed pretest for leakage test using bubble emission technique, check for sticky triggers and check roundness of housing.It was noted in the service order that the oscillate function did not work.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 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|