(b)(4).Batch # u9459p.Investigation summary: the analysis results found that the el5ml device was received with one jaw disengaged from the cam.This condition would not allow the jaws to collapse in order to form the clips.No functional test was performed due the condition of the device.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.In addition, 3 clips were found inside clip track.Possible causes for the condition of the jaw disengaged from the cam may be inadvertent force, twisting or pressure being placed on the device jaws, using the jaws of the device as a dissector/retractor, or damage to the jaws while entering the trocar.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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It was reported that during a laparoscopic cholecystectomy, the physician was doing the procedure when the 5ml clip applied broke after three clips.They opened a second applier and finished without incident.It was only closing the tip of the clip so it looked like a diamond shape wrapped around the vessel, but not occluded.It was ejecting clips before the jaw could squeeze it closed.Patient consequence was not reported.
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