Model Number N/A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2 ¿ foreign - france.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the battery cover is defective at the closure part.Due diligence is in progress for this complaint; to date no additional information has been received.This event is related to a malfunction that could potentially lead to a sterility issue/serious injury.However, no patient harm or further outcome was reported.
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Manufacturer Narrative
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Upon receipt, the device was functional.The reported issue could not be duplicated.A definitive root cause cannot be determined as there was no problem found.Device is used for treatment.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.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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