According to the reporter, during a laparoscopic procedure, a piece of the equipment had become detached from the instrument, and was retrieved using a grasper and removed from the surgical area.The device retractor was immediately removed from surgery, bagged, broken piece was placed in a specimen pot and into bag.A new instrument was opened in order to complete the case.
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Correction: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Clevis piece was broken along plane of pin attachment.Distal end of handle was split open.Shaft had disengaged from handle of device.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 reported condition may occur as a result of the instrument being forced beyond it indicated use due to applying excessive stress over the clevis.The plastic clevis was broken from the pin hole; which is consistent with the use of excessive force during the procedure, thus causing the unit clevis to break and the distal end of the handle to partially split open.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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