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Model Number EMAX2PLUS |
Device Problems
Device Alarm System (1012); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2022 |
Event Type
malfunction
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Event Description
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It was reported from the united kingdom that the motor device was showing an e06 error code (overheat warning) when plugged into the console device.It was reported that this error code flags immediately even after handpiece device had been left to cool.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.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 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.Additional narrative: 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.Additional information b5: during subsequent follow-up with the affiliate, additional information was obtained.The reporter stated that the device did not overheat.This information does not change the reportability of the file and remains a reportable 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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.A review of the device history was performed and no non-conformances were detected related to the reported condition.
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Search Alerts/Recalls
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