Model Number N/A |
Device Problems
Loss of Power (1475); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, the device was operating intermittently.There was no harm reported but there was a 0-15 minute delay in procedure while the patient was under anesthesia.Another device was used to complete the procedure.Due diligence is in progress for this complaint; to date no additional information or product has been received.No adverse events are associated with this malfunction.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 telephone number: (b)(6).
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Event Description
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There is no additional information regarding the event available.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.The reported electrical contact issue could not be replicated; no problem found.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.G2 country: france.
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Search Alerts/Recalls
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