Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT WAS REPORTED AS A COMPLAINT ON (B)(6) 2021. THE EVENT OCCURRED AT (B)(6) HOSPITAL, WHICH IS LOCATED IN THE (B)(6). THE EVENT INVOLVED TWO SENHANCE MANIPULATOR ARMS (X9000005, UDI: (B)(4), SERIAL NUMBERS (B)(4)) AND TWO JOHAN GRASPERS 15 MM Ø 5 MM X 310 MM (X0007005, UDI: (B)(4), LOT: 1845171). THE TIME OF OCCURRENCE WAS DURING A SURGICAL CASE AND THE SURGICAL PROCEDURE WAS FOR TREATMENT OF MALROTATION VOLVULUS. THE PATIENT WAS A (B)(6) CAUCASIAN FEMALE WITH WEIGHT OF (B)(6) AND BMI OF 29.2. THE SENHANCE SYSTEM AND ASSOCIATED DEVICES ARE NOT INDICATED FOR PEDIATRIC USE IN THE US. AS INITIALLY REPORTED BY THE COMPLAINANT, DURING THE CASE THE SMALL INTESTINE WAS PERFORATED 2 TIMES WITH THE JOHAN GRASPER. WHEN HOLDING THE TISSUE WITH THE GRASPER, THE TISSUE TURNED WHITE DUE TO THE GRASPING FORCE. AFTER STITCHING BOTH PERFORATIONS, THE SURGEON COULD CONTINUE WITH THE CASE. THE USE OF TWO JOHAN GRASPING FORCEPS CAUSED HEMATOMA OF THE SEROSA AND EVENTUALLY 2 PERFORATIONS OF THE SMALL INTESTINE. THE FOOTPRINT OF EVERY BITE WAS VISIBLE ON THE TISSUE. THE PROCEDURAL DELAY WAS LESS THAN 15 MINS. ADDITIONAL QUESTIONS WERE POSED TO FURTHER INVESTIGATE THE IMPACT ON THE PATIENT. THERE