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Catalog Number 05.001.201 |
Device Problems
Circuit Failure (1089); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2022 |
Event Type
malfunction
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Event Description
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It was reported by germany that during service and evaluation, it was determined that the trigger of the battery handpiece device was sticky.It was further observed that the device was difficult to assemble/disassemble and missing labeling.It was determined that the device failed leak tightness test and device¿s moving parts did not move smoothly.It was further observed that the device had seized bearing.It was further determined that the device failed pretest for checking for cannulation, leakage test using bubble emission technique, checking for mechanical free movement and checking for sticky triggers.It was noted in the service order that the device had no battery connection.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.
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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 initial reported condition that the device had no battery connection was not confirmed.Therefore, an assignable root cause was not determined.However, the trigger of the device 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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