Model Number AD750-KE35 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 03/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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Coopersurgical, inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not been returned.Once the investigation is completed a follow up report will be filed.(b)(4).Device not returned.
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Event Description
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"the vagina got caught under the lock groove and caused a defect wound in the vagina that required the surgeon to stitch and repair it." (b)(4).
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Manufacturer Narrative
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The reported complaint of the lock slipping and not being able to hold the koh in place cannot verified due to the absence of the affected sample in that it will not be returned.However, if the affected sample is returned in the future the complaint may be reopened and addressed as needed.R& d engineering has launched an investigation to evaluate similar complaints as part of a cip task.It should be noted that past returned device samples that were returned for similar reported incidents were not reproducible.Evaluation tests were performed by r&d engineering on identical devices by placing thirty (30lbs) pound weights atop the adapter drape when locked onto the tube, and could not replicate the reported events of the latch not holding; tests were performed in dry and wet states.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).A review of (b)(4) were performed and both documents addressed the reported event with proper process controls or verification(s) for clear tip attachment.
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Event Description
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During the case, the locking mechanism would flip up and become unlocked whenever the surgeon was pushing with cephalad pressure.She repeatedly had to re-lock the device mechanism.In a previous case when the doctor was evacuating the uterus, the lock flipped up, so the surgeon pressed the lock down.The vagina got caught under the lock groove and caused a defect wound in the vagina that required the surgeon to stitch and repair it.
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Search Alerts/Recalls
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