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 ON DAY 6, THERE WAS AN ANASTOMOTIC LEAKAGE DETECTED, THEN CLINICALLY AND DIGITALLY CONFIRMED. PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY (METRONIDAZOLE-500 MG 3X DAILY; CEFUROXIME-1 G 3X DAILY) AND HAD A PROLONGED HOSPITAL STAY BUT RECOVERED FOR A (B)(6) 2020 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THIS EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 10-AUGUST-2023.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, DR. (B)(6), REPORTED A PATIENT BLADDER RUPTURE FOR WHICH SURGICAL INTERVENTION WAS NEEDED. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE, BUT WITHOUT ANY FURTHER DETAILS PERTAINING TO PATIENT TREATMENT OR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN FELDKIRCH REGIONAL HOSPITAL IN AUSTRIA. ADDITIONALLY, THIS EVENT OCCURRED ON 16-OCTOBER-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 07-SEPTEMBER-2022.

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 ON DAY 7, AFTER TME FOR RECTAL CANCER PATIENT COMPLAINED OF SUDDEN PURULENT DISCHARGE FROM THE ANUS AND ELEVATED BLOOD TEMPERATURE, SOME WEAKNESS. THIS ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. A DIGITAL EXAMINATION REVEALED A DEFECT OF (1 CM) IN THE POSTERIOR WALL OF COLO-ANAL ANASTOMOSIS. ANTIBIOTICS WERE ADMINISTERED (METRONIDAZOLE-500 MG 3X DAILY AND CEFUROXIME-1 G 3X DAILY) AND SYMPTOMS DISSAPEARED FOR A RESOLUTION DATE OF (B)(6) 2020. 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) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 09-AUGUST-2023..

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, VAIDA NAUSEDIENE, REPORTED THAT ON DAY 4, THE PATIENT DEVELOPED FEVER, SIGNS OF PERITONITIS. THE ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. ON (B)(6) 2020, PATIENT WAS RE-OPERATED VIA LAPAROTOMY, DISRUPTION OF ANASTOMOSIS, LAVAGE AND DRAINAGE OF THE ABDOMEN, END COLOSTOMY. PATIENT WAS THEN TREATED IN ICU, THUS POSTOPERATIVE COURSE AND RECOVERY WAS LONGER DUE TO INFECTION OF THE LAPAROTOMY WOUND, WITH OBESITY AND CO-MORBIDITIES PRESENT. PATIENT RECOVERED AND WAS DISCHARGED FOR A 20-MARCH-2020 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THE EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON 29-FEBRUARY-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 16-AUGUST-2023.