Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6) REPORTED THAT THE PATIENT UNDERWENT TOTAL MESORECTAL EXCISION ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT COMPLAINED OF FEVER, GENERAL DISCOMFORT, AND WEAKNESS. A DIGITAL EXAMINATION CONFIRMED THAT THE ANASTOMOSIS WAS NORMAL. AS FEVER WAS 39.5 AND SUDDEN, IN ORDER TO BE SURE THAT THERE WAS NO ISCHEMIC CHANGES IN THE COLON WHICH WAS BROUGHT TO SMALL PELVIS FOR COLO-ANAL ANASTOMOSIS, FLEXIBLE PROCTOSCOPY WAS DONE. IT REVEALED NECROTIC DISTAL COLON (APPROX. 5-10 CM) ABOVE ANASTOMOSIS. AN URGENT LAPAROTOMY WAS PERFORMED: THE COLON WAS BROUGHT FROM SMALL PELVIS, RESECTED, AND TERMINAL COLOSTOMY WAS DONE SAME DAY. ANUS (VERY SHORT RECTAL STUMP) WAS CLOSED WITH PURSESTRING SUTURE. THE SURGICAL FOLLOW-UP WAS UNEVENTFUL, BUT DUE TO URINARY RETENTION ON (B)(6) 2023 AN EPICYSTOSTOMY WAS PERFORMED FOR A DATE OF RESOLUTION ON (B)(6) 2023. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THE EVENT OCCURRED ON (B)(6) -2023 AND ASENSUS SURGICAL WAS MADE AWARE ON 08-SEPTEMBER-2023.