Model Number AD750-KE35 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Uterine Perforation (2121)
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Event Date 05/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complaete a follow up report will be filed.(b)(4).
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Event Description
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(b)(4)."while the surgeon was manipulating and applying cephelad pressure the delineator perforated through the uterus.The product was disposed immediately due to the malignancy cells in the uterus.".
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Manufacturer Narrative
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Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is complete a follow up report will be filed.Ref: e-complaint-(b)(4).*investigation: initiated manufacturer's investigation.No sample returned.*analysis and findings: the reported event cannot be verified due to the absence of the affected device at the time of this investigation.However, if the affected device is returned in the future, and made available for investigative analysis the complaint may be reopened and addressed as needed.This device is oem manufactured for csi which sends it to another outside contractor for sterilization and distributes it from fg warehouse (b)(4).All devices are is 100% inspected by the oem before being shipped to csi in (b)(4).*correction and/or corrective action: corrective action is not warranted at this time due to the absence of the affected device for proper investigative analysis.Reason: per (b)(4), this complaint will be monitored for trending in that no injury was reported to end user or patient.*was the complaint confirmed? no.
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Event Description
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Reference e-complaint-(b)(4)."while the surgeon was manipulating and applying cephalad pressure the delineator perforated through the uterus.The product was disposed immediately due to the malignancy cells in the uterus.".
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Search Alerts/Recalls
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