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Model Number EMAX2PLUS |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/02/2020 |
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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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It was reported that during post-surgery, while the motor device was being cleaned, it was observed that it displayed an e6 error code (handpiece overheat warning, impending handpiece shutdown).The event was not related to surgery.There was no patient involvement reported.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 report will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device displayed an e6 error code (handpiece overheat warning, impending handpiece shutdown) and the flex circuit was damaged.It was further determined that the device had a component damage, would not run, and the device ran in locked position - power broken.It was determined that the pawl was released, and the cylinder was locked.It was further determined that the device failed pretest for cable assessment, no short circuit between phases and connector body, safety assessment and rotational speed assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.
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Search Alerts/Recalls
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