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 one elevator broke and one elevator bent during a procedure.There was no delay that exceeded thirty minutes, all parts were retrieved and no injury to the patient.
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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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Two elevator #301's were returned under this lot for evaluation.According to the evaluation, the complaint was confirmed as the tip of one elevator was found to be fractured off; the tip of the other elevator was found to be bent.For both elevators, the most-likely underlying cause was determined to be excessive force.The non-conformance database was reviewed in the product evaluation and no non-conformances were found for this lot.There are no indications of manufacturing defects.The instructions for use state, "the tip of the instrument is extremely thin and delicate; care should be taken to avoid applying significant pressure to the tip.".
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Search Alerts/Recalls
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