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Catalog Number 05.001.201 |
Device Problems
Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Event Description
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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 labeling was illegible and etching.It was further observed that the device had a leak tightness test failure, would not hold/secure the battery device, and the moving parts did not move smoothly.It was further determined that the device failed pretest for marking and labeling, leakage test using bubble emission technique, check for mechanical free moving, check for sticky triggers and check falling out protection (steel ring).It was noted in the service order that the device had an undetermined malfunction.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.
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Manufacturer Narrative
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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 trigger being sticky, identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.Udi: (b)(4).
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Search Alerts/Recalls
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