Model Number AD750-KE35 |
Device Problems
Break (1069); Fire (1245)
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Patient Problem
Burn(s) (1757)
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Event Date 02/07/2017 |
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 complete a follow up report will be filed.(b)(4).
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Event Description
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(b)(4).The cup made fire in contact with electrosurgical device, made a small burn in the vagina.The tip is broken.
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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.(b)(4).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.It has been affirmed by the resident (b)(4) that it is possible to have arcing occur while using the device along with electrocautery devices.The evidence on the koh-efficient cup is not out of the ordinary and commonly found on other used devices and may be attributed to incorrect user technique.This device is oem manufactured for csi which sends it to another outside contractor for sterilization and distributes it from (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 as this event result has been acknowledged as a normal occurrence by the csi resident (b)(4).
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Event Description
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(b)(4).The cup made fire in contact with electrosurgical device, made a small burn in the vagina.The tip is broken.
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Search Alerts/Recalls
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