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Model Number EMAX2PLUS |
Device Problems
Fail-Safe Problem (2936); Complete Loss of Power (4015); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Event Description
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It was reported by india that during service and evaluation, it was determined that the motor device was generating heat and ran in locked position.It was further observed that the device was making excessive noise.It was further determined that the device failed pretest for safety assessment, noise assessment and handpiece temperature assessment.It was noted in the service order that the device 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 2022.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 heat and device running in locked position identified during service and evaluation were confirmed.The assignable root cause was determined to be traced to component failure from wear.Udi: (b)(4).
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Search Alerts/Recalls
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