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Model Number EMAX2PLUS |
Device Problems
Unintended System Motion (1430); Separation Failure (2547); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/07/2021 |
Event Type
malfunction
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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.Concomitant med products and therapy dates: attachment device, burr device, (b)(6) 2021.Device evaluation: the actual 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 determined to be due to component failure from normal wear.Udi: (b)(4).
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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 motor device had a worn bearing, locking components damaged, excessive noise and unintended activation/motion.It was further determined that the device failed pretest for safety assessment and noise assessment.It was observed that the short attachment device and cutter device could be easily removed from the motor device.It was noted in the service order that the motor device hand piece had a short attachment device with an unknown cutter device jammed and could not be released from the drill hand piece.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 available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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