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Catalog Number EMAX2PLUS |
Device Problem
Device Alarm System (1012)
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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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Event Description
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It was reported from taiwan that the motor device displayed an e6 error code indicating handpiece overheat warning, and e8 error code indicating system fault.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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 2023.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.E1: the reporter¿s phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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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 reported condition of the displaying an e6 error code indicating handpiece overheat warning was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device displayed an e8 error code indicating system fault and would not run due to a motor damage.It was further determined that the device failed pretest for motor thermistor assessment and safety assessment.The assignable root cause was determined to be traced to user, which is user error.
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Search Alerts/Recalls
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