COLONIC FTRD SET

Additional Manufacturer Narrative

IN SUMMARY, THERE IS NO INDICATION OF A TECHNICAL FAILURE OF THE DEVICE. NONE OF THE DMRS SHOWED ANY DEVIATION. COLONIC PERFORATION IS IN GENERAL A KNOWN AND COMMON COMPLICATION IN ADVANCED ENDOSCOPIC RESECTION TECHNIQUES. THE RISK OF CAUSING A PERFORATION IS INDICATED IN THE INSTRUCTION FOR USE OF FTRD, TOO. MOREOVER, IT IS ADDRESSED IN USER TRAININGS WE PERFORM. IT IS RECOMMENDED TO VERIFY 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 >2 CM SIZE LESION IN THE CECUM. THE ENDOSCOPIC INTERVENTIONIST ASSUMED THAT THE CLIP OF THE COLONIC FTRD SET IN QUESTION HAD BEEN SUCCESSFULLY APPLIED AND, HENCE, PROCEEDED TO PERFORM THE FULL THICKNESS RESECTION. HOWEVER, CLIP APPLICATION WAS VISUALLY NOT VERIFIED BEFOREHAND. THE PERFORATION CAUSED WAS CLOSED BY SURGERY. AS REPORTED TO US THE PATIENT RECOVERED UNEVENTFULLY FROM THE SURGICAL PROCEDURE.