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Catalog Number EMAX2PLUS |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
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 the initial medwatch, a follow-up medwatch 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 reported condition was confirmed.The assignable root cause was determined to be due to user error.(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 had an air leak, liquid leak, heat, corrosion/rusting/pitting and cord damage.It was further determined that the device failed pretest for visual, no short circuit, air pump assessment and handpiece temperature.It was noted in the service order that the end of the device hose was disconnected.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 unknown.However, it was reported that the event occurred in 2024.All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.
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Search Alerts/Recalls
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