Catalog Number 0250080767 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 the instrument broke off at the tip.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: the instrument broke off at the distal tip.-instrument pieces were salvaged.The failure(s) identified in the investigation is consistent with the complaint record.Probable root causes could be user excessive force, or handling during cleaning/sterilization.The device manufacturer date is not known.(b)(4).
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Event Description
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It was reported the instrument broke off at the tip.
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Search Alerts/Recalls
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