HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES, AND USER MANUAL (UM). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HY1000T-US/SERIAL NUMBER (B)(6), WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE SYSTEM MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE TREATMENT SESSION LOGS WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS AND WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, REV. C, WAS REVIEWED. 4.3.3 PRECAUTIONS: PROCEDURE. - MONITOR THE PATIENT FOR BLADDER OVERDISTENSION THROUGHOUT THE PROCEDURE. PAUSE TREATMENT TO ALLEVIATE THE SOURCE OF BLADDER OVERDISTENSION PRIOR TO CONTINUING. 4.2.3 WARNINGS: PROCEDURE. - AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE THE FOLLOWING, SOME OF WHICH MAY LEAD TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: BLADDER OR PROSTATE CAPSULE PERFORATION. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT THE SURGEON NOTICED A BLADDER PERFORATION DURING HEMOSTASIS. IT WAS SURGICALLY REPAIRED. AS PER THE TREATING SURGEON THE PATIENT'S OVERDISTENDED BLADDER DURING THE TREATMENT CAUSED THE PERFORATION. THE PATIENT HAS SINCE BEEN DISCHARGED AND RECOVERING WELL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. THE HYDROS ROBOTIC SYSTEM'S UM LISTS BLADDER PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND UM, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING HEMOSTASIS, THE TREATING SURGEON IDENTIFIED A BLADDER PERFORATION. AS PER THE TREATING SURGEON, IT WAS LIKELY DUE TO THE PATIENT'S OVERDISTENDED BLADDER DURING THE PROCEDURE, BUT THE SURGEON WAS UNSURE WHEN IT HAD OCCURRED. THE BLADDER WAS SURGICALLY REPAIRED, AND THE PATIENT HAS SINCE BEEN DISCHARGED AND IS RECOVERING WELL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.