Hugo RAS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

Hugo RAS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING THE RESECTION AND INCISION OF SURROUNDING TISSUE, SUCH AS THE BLADDER AND URETHRA, FOR A ROBOT-ASSISTED LAPAROSCOPIC PROSTATE RESECTION PROCEDURE, ONE INSTRUMENT WAS BEING USED TO REMOVE CHARRED RESIDUE FROM ANOTHER INSTRUMENT AND A COLLISION OCCURRED. AN APPROXIMATELY 3MM PIECE OF THE MONOPOLAR CURVED SHEARS JAW TIP CHIPPED OFF AND FELL INTO THE PATIENT. THE PIECE FELL IN THE VICINITY OF THE DORSAL ASPECT OF THE SMALL INTESTINE IN THE RIGHT LOWER ABDOMEN. ADDITIONAL TASKS DURING THE PROCEDURE WERE PERFORMED, INCLUDING MOBILIZATION OF THE INTESTINAL TRACT TO SEARCH FOR FRAGMENTS AND FURTHER LAPAROSCOPIC MANIPULATIONS. THE LOCATION OF THE DISENGAGED PIECE WAS IDENTIFIED VIA INTRAOPERATIVE X-RAY, WHILE BEING MONITORED IN REAL TIME, AND ULTIMATELY RETRIEVED USING A SUCTION TUBE. THE PROCEDURE WAS EXTENDED BY FORTY-FIVE MINUTES DUE TO THE ISSUE. ADDITIONAL SURGERY WILL NOT BE REQUIRED.