Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyscope ds ii was analyzed, and a visual evaluation noted that there were elevator marks on the shaft of the catheter.Visual inspection of the external shaft at the distal end of the device showed damage in the form of a small tear and peeling of the light-blue layer of polytetrafluoroethylene (ptfe).The handle was opened, and the breakout region of the handle was visually inspected.There was procedural residue seen in the plastic optic fibers (pof) indicating that the device was used.The reported complaint regarding device damaged/defective was confirmed.During product analysis, signs of use in the form of witness marks and procedural residue at the pofs were noted.Visual inspection of the external shaft at the distal end confirmed damaged in the form of a small tear and peeling of the light-blue layer of ptfe.Based on the presence and location of the damage to the external shaft, it is likely that interaction with the combination device (i.E., duodenoscope) led to the observed tear and peeling of the external ptfe.Based on the event description, the damage to the sheath was observed after the catheter was fed through the duodenoscope, which likely means the external shaft of the catheter was damaged as the catheter was being inserted through the combination device.Based on all gathered information, the probable cause selected for the reported problem is adverse event related to procedure, which indicates that the device complaint or problem occurred during the procedure and the device had no influence on event.
|