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Model Number 8886848813 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during laparoscopic cholecystectomy procedure, , the surgeon fired the device it failed.The clip slipped from the cystic duct.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual examination of the first cartridge noted that the clip was fully formed but not completely deployed from the cartridge.Since the clinical instrument was not received the first loading unit was loaded into a pmv representative instrument and fired; the pusher advanced properly and deployed the clip.The inspection of the second cartridge noted it was received not applied.Functionally; the second cartridge was loaded into the pmv representative instrument, the firing handle was actuated and the clip formed properly onto the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the clip not fully deployed condition may occur if the trigger of the instrument is not fully actuated releasing the clip from the cartridge.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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