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Model Number EMAX2PLUS |
Device Problems
Material Frayed (1262); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2022 |
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.The actual device was returned for evaluation.During repair, an evaluation was performed and the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the motor device was making excessive noise, had an air leak, the flex circuit was damaged, component damage, heat, and cord damage.It was further determined that the device failed pretest for visual assessment, motor thermistor assessment, no short circuit between phases and connector body, no short circuit between hall sensors and connector body, no short circuit between 5vdc line and connector body, no short circuit between sensor gnd and connector body, noise assessment, air pump assessment, and handpiece temperature assessment.It was noted in the service order that the motor device hose ruptured.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.The actual device was returned for evaluation.During repair, an evaluation was performed and the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the motor device was making excessive noise, had an air leak, the flex circuit was damaged, component damage, heat, and cord damage.It was further determined that the device failed pretest for visual assessment, motor thermistor assessment, no short circuit between phases and connector body, no short circuit between hall sensors and connector body, no short circuit between 5vdc line and connector body, no short circuit between sensor gnd and connector body, noise assessment, air pump assessment, and handpiece temperature assessment.It was noted in the service order that the motor device hose ruptured.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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