[2602]
When disposable trocar was removed from abdomen, a portion of the safety shield was retained. It was visualized through the scope, protruding from the peretoneum. This piece was removed and the trocar was checked tobe sure it was there in its entirety. When dr. X handed the obturator of the trocarback to me i noticed a piece was missing from the end. It was visible through the scope sticking out into the peretoneum. It was retrieved and pulled out. The rest of the obturator was inspected and was found to have another small piece inside. The incision was checked and had no other pieces. The remaining trocars removed from availability. Sales rep contacted. Rep says sthis has happened several times before and a new trocar with a reinforced shield has been manufactured. These were ordered on 6/28 to arrive 7/2. In the meantime us. Surical trocars will be used if necessary. Piece of shield removed from abdomendevice labeled for single use. Patient medical status prior to event: unknown. 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: visual examination. Results of evaluation: component failure, telemetry failure, none or unknown, other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor, use of all similar devices stopped permanently, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5