Model Number N/A |
Device Problems
Leak/Splash (1354); Device Emits Odor (1425); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is recorded with zimmer biomet under (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during the surgery, this complaint product made abnormal noise and gave out an offensive smell after 4000ml irrigated.Therefore, the surgeon used an alternative one to complete the surgery.Initial inspection of the product found that liquid had leaked from the batteries.No adverse events have been reported as a result of this malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Result code which states "current leakage problem" for the "battery leakage".Review of the device history record identified no relevant deviations or anomalies.Product examination found that there was leakage from the batteries.Some of the battery contacts were badly corroded.This complaint is confirmed.The root cause of the reported event could not be determined with the information provided on this complaint.The cause of this battery failure could not be ascertained.Also, the source of the abnormal noise could not be determined as the product was returned in a nonfunctioning condition.Leaking batteries may account for the reported smell.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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Search Alerts/Recalls
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