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. IT WAS REPORTED THAT POST-AQUABLATION THERAPY, THE TREATING SURGEON PLACED A ROUSH CATHETER TIP AND CREATED A SMALL, THUMBNAIL-SIZED HOLE IN THE ANTERIOR WALL OF THE BLADDER. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR THE SURGICAL REPAIR OF THE BLADDER. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED THE NEXT DAY. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HY1000T-US/SERIAL NUMBER 25C03839, 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 HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, REV. C, WAS REVIEWED. 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'S USER MANUAL LISTS BLADDER PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE DHR, AND UM, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. 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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE TREATING SURGEON PLACED A ROUSH CATHETER TIP AND CREATED A SMALL, THUMBNAIL-SIZED HOLE IN THE ANTERIOR WALL OF THE BLADDER. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR THE SURGICAL REPAIR OF THE BLADDER. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED THE NEXT DAY. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.