[15613937]
Instrument malfunction became evident when dr. Was ready to do the cholangiogram. When dr. Tried to removed the disposable endoscopic tissue manipulator, the release would not function. The fingers of the manipulator would not fold together for removal. At this time it was ecided by the dr. To leave the retractor in place while the cholangiogram was taken. At the conclusion of the case one arm on the tissue manipulator was broken and the dr. Was unable to pull it back out through the trocar and had to remove it through to abdominal opening with the manipulator unretracted. The dr. Stated he was retracting the omentum for better visualization. The instrument apparemntly sprung and would not release. The instrument and trocar were removed together under camera visualization. Dr. Examined the instrument and felt all parts were accounted for. The patient was discharged the next day with no apparent complication at that time. The patient is scheduled for an office visit late in the week of november 2. Ethicon representative notified of instrument malfunctiondevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5