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Model Number EMAX2PLUS |
Device Problems
Unintended System Motion (1430); Overheating of Device (1437); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2021 |
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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device not starting was not confirmed.Therefore, an assignable root cause was not determined.However, the reported conditions of unintended activation/motion and heat were 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 cable and cord of the motor device were damaged.It was further observed that the device had a component damage, unintended activation/motion, heat, and could not secure/lock the cutter device.It was further determined that the device failed pretest for visual assessment, cable assessment, cutter lock assessment, safety assessment and hand piece temperature assessment.It was noted in the service order that after a craniotomy surgery, it was discovered that the device did not start.It was reported that there were no delays in surgery and the procedure was completed as intended.It was further reported that a spare device was available for use.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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Search Alerts/Recalls
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