COLONIC FTRD SET

Additional Manufacturer Narrative

AS DESCRIBED THE CLIP WAS INTENDED TO BE PLACED IN THE CECUM FOR RESECTION OF A TUBULAR ADENOMA. THE TISSUE MOBILIZATION WAS CLASSIFIED AS DIFFICULT. IT WAS MENTIONED THAT THE MOBILIZATION OF THE FRIABLE AND FIBROTIC TISSUE COULD BE FINALLY MANAGED AFTER 3 TRIALS, WHILE USING GRASPER AND SUCTION ADDITIONALLY. THE RISK OF CAUSING A USE SEQUENCE MISTAKE IS INDICATED IN THE INSTRUCTION FOR USE. MOREOVER, IT IS ADDRESSED IN USER TRAININGS WE PERFORM. IT IS RECOMMENDED TO VERIFY A SUCCESSFUL CLIP APPLICATION BEFORE RESECTING THE TARGET TISSUE. IN CONCLUSION, THE DETERMINED ROOT CAUSE IS A PROCEDURAL COMPLICATION, NOT A TECHNICAL FAILURE. .

Description of Event or Problem

A COLONIC FTRD SET (CFTRD), MANUFACTURER OVESCO ENDOSCOPY AG, WAS USED FOR AN ENDOSCOPIC FULL THICKNESS RESECTION OF A COLONIC POLYPOID LESION. THE ENDOSCOPIC INTERVENTIONIST ASSUMED THAT THE CLIP OF THE COLONIC FTRD STE IN QUESTION HAD BEEN SUCCESSFULLY APPLIED AND, HENCE, PROCEEDED TO PERFORM THE FULL THICKNESS RESECTION. HOWEVER, CLIP APPLICATION WAS NOT VISUALLY VERIFIED BEFOREHAND. AFTER RESECTION OF THE LESION, THE PERFORATION WAS QUICKLY RECOGNIZED. THE PHYSICIAN RE-ADVANCED THE FTRD CAP TO THE PERFORATION AND USED THE FTRD GRASPER TO PULL THE TISSUE INTO THE FTRD AND ENDOSCOPIC SUCTION. THEN HE APPLIED THE FTRD CLIP CLOSING THE PERFORATION PARTIALLY. IN ADDITION, HE USED ENDOSCOPIC CLIPS TO CLOSE THE REST OF THE PERFORATION. AFTER SEEMINGLY CLOSING THE PERFORATION THE PATIENT WAS KEPT IN HOSPITAL OVERNIGHT FOR EVALUATION. HOWEVER, A CT SCAN THE FOLLOWING MORNING REVEALED THAT THE PERFORATION HADN'T BEEN FULLY CLOSED AND SURGICAL REPAIR WAS DONE BY COLONIC RESECTION. THE PATIENT RECOVERED UNEVENTFULLY AFTER SURGERY.