COLONIC FTRD SET

Additional Manufacturer Narrative

DUE TO THE STATEMENT OF OVESCO'S SAFETY OFFICER, SUCH PERFORATION CAN OCCUR IN VERY RARE CASES AND ARE KNOWN AS A POSSIBLE COMPLICATION, ALSO BECAUSE THE DEVICES ARE A BIT LARGER AS THEY ARE ATTACHED TO THE TIP OF THE ENDOSCOPE. HOWEVER, AS NO RESECTION ITSELF DID HAPPEN, THE FAILURE IS CONSIDERED AS PROCEDURE RELATED AND NOT CAUSED BY ANY DEVICE MALFUNCTION.

Description of Event or Problem

PERFORATION OF SIGMOID COLON DURING PROCEDURE WITH COLONIC FTRD, MANUFACTURER OVESCO ENDOSCOPY AG. IT WAS REPORTED THAT THE PATIENT'S SIGMOID COLON WAS PERFORATED WHILE ATTEMPTING TO REACH THE ASCENDING COLON. THE PERFORATION HAPPENED DURING ADVANCEMENT OF THE SCOPE AFTER THE EMR HAS BEEN CONDUCTED AND MUST HAD BEEN CLOSED SUBSEQUENTLY BY SURGERY. WHILE THE PATIENT RECOVERED WELL, HE COULD BE DISCHARGED FROM THE HOSPITAL AFTER A FEW DAYS.