Catalog Number 544965 |
Device Problems
Entrapment of Device (1212); Difficult to Remove (1528)
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Patient Problem
No Information (3190)
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Event Date 05/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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During use the applier stuck in the closed position intra-abdominal on the cystic duct and was not possible to re-open it or remove it.The cystic duct had to be cut around the applier.The patient's condition was reported as unknown.
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Manufacturer Narrative
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(b)(4).Since this instrument was not returned for evaluation and lot information has not been provided, we are unable to determine where and when it was produced or perform a thorough dhr review at this time.Since the instrument was not returned for evaluation and pictures were not provided, we are unable to validate this complaint or determine root cause at this time.All instruments are thoroughly inspected and function tested at time of manufacture.
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Event Description
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During use the applier stuck in the closed position intra-abdominal on the cystic duct and was not possible to re-open it or remove it.The cystic duct had to be cut around the applier.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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