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 DURING AQUABLATION THERAPY IT WAS OBSERVED THAT THE PATIENT EXPERIENCED BLADDER PERFORATION AFTER THE FIRST PASS OF AQUABLATION. THE SURGEON STATED THAT THE EVENT WAS RELATED TO THE ASPIRATION TUBING BEING ON BACKWARDS AND THAT THERE WAS NO MEDICAL INTERVENTION NEEDED. PATIENT IS WELL AND HAS BEEN DISCHARGED. 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HY1000-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 HYDROS ROBOTIC SYSTEM'S TREATMENT LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE AND INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. 4.2.3 WARNINGS: PROCEDURE: AVOID APPLYING EXCESSIVE COMPRESSION TO THE PROSTATE. EXCESSIVE COMPRESSION CAN CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. 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. 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, DURING AQUABLATION THERAPY, THE PATIENT EXPERIENCED A BLADDER PERFORATION. THE TREATING SURGEON DETERMINED THAT THE PERFORATION OCCURRED DURING THE PROCEDURE FOLLOWING THE INITIAL PASS, AT WHICH TIME THE PATIENT'S BLADDER WAS OVERDISTENDED, AND THE PATIENT EXHIBITED SUDDEN BUCKING MOVEMENT. THE SURGEON FURTHER STATED THAT IT WAS POTENTIALLY RELATED TO THE ASPIRATION TUBING BEING INSTALLED BACKWARD DURING SETUP. THE SURGEON ALSO DETERMINED THAT NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.