Model Number N/A |
Device Problems
Bent (1059); Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The warnings in the package insert state this type of event can occur.Because the lot number is unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that six elevator #301's were broken and/or bent during different surgeries.There was no delay in any of the surgeries, all parts were retrieved in each case, and there was no injury to the patients.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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The product was returned for evaluation.According to the product evaluation, the complaint is confirmed as the tip of the elevator is slightly bent.The most-likely, underlying cause of the complaint was determined to be excessive force.The instructions for use states, "the tip of the instrument is extremely thin and delicate; care should be taken to avoid applying significant pressure to the tip." the non-conformance database was reviewed in the product evaluation and no non-conformances were found for this lot.There is no indication of manufacturing defects.This is report 1 of 6 for the same event.Reports 2 through 6 are reported on mfr # 0001032347-2016-00263-1 through 0001032347-2016-00267-1.
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Search Alerts/Recalls
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