Model Number UNVCA12STF |
Device Problems
Leak/Splash (1354); Device Packaging Compromised (2916); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/02/2017 |
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 partial colectomy procedure, the device versa seal was broken at the beginning when the surgeon try to pass the permanent/reusable clip applier.The seal had air or gas leak and device made a strange noise.Another device was used to complete the procedure.No patient injury has been noted.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the trocar only was received.The circular seal was cut.The condition in which the device was received precludes functional testing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the cut circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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