Catalog Number 0747031560 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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It was reported during surgery the device broke off inside the patient.All the broken pieces were retrieved from the patient.The procedure was completed successfully with no adverse consequences to the patient.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: valve broke.Probable root cause: poor autoclave reliability.Incorrect sterilization/reprocessing procedure.Handling procedures.Use error.The failure mode will be monitored for future reoccurrence.Mfg date: manufacture date is not known.(b)(4).
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Event Description
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It was reported during surgery the device broke off inside the patient.All the broken pieces were retrieved from the patient.The procedure was completed successfully with no adverse consequences to the patient.
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Search Alerts/Recalls
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