Catalog Number 0250070442 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Mfg date: the device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the tip was broken during a procedure.It was also confirmed that all pieces were retrieved.
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Event Description
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It was reported that the tip was broken during a procedure.It was also confirmed that all pieces were retrieved.
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Manufacturer Narrative
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Alleged failure: tip fell off.Probable root cause: material/design error.Manufacturing/assembly error.Excessive user force.Severe shipping conditions.Disposable tip rubbing against product.User error.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Search Alerts/Recalls
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