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Catalog Number EMAX2PLUS |
Device Problems
Device Alarm System (1012); Unintended System Motion (1430)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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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: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had unintended activation/motion and was displaying an e8 error code.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is improper maintenance.Udi - (b)(4).
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Event Description
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It was reported from switzerland that during service and evaluation, it was determined that the motor device motor was damaged ¿ will not run, was displaying an e8 error code (system fault), and had unintended activation/motion.It was noted that device was damaged by liquid because of improper reprocessing.It was further determined that the device failed pretest for visual assessment, motor thermistor assessment, and safety assessment.It was noted in the service order that the device was displaying an e8 error code.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 not reported, however, it was reported that the event occurred in 2023.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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