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 FOCAL BLADDER NECK CAUTERY (FBNC), UPON INSERTION OF THE RESECTOSCOPE, IT WAS OBSERVED THAT THE PATIENT'S BLADDER COULD NOT MAINTAIN DISTENTION. THE PHYSICIAN USED A CYSTOSCOPE AND IDENTIFIED THAT THE PATIENT'S BLADDER WAS PERFORATED. THE PATIENT REQUIRED OPEN SURGICAL REPAIR FOR THE BLADDER PERFORATION. THE SURGEON DOES NOT ATTRIBUTE AQUABLATION THERAPY TO THE PERFORATION. THE 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. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, REV. C, WAS REVIEWED. 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 FOCAL BLADDER NECK CAUTERY (FBNC), UPON INSERTION OF THE RESECTOSCOPE, IT WAS OBSERVED THAT THE PATIENT'S BLADDER COULD NOT MAINTAIN DISTENTION. THE PHYSICIAN USED A CYSTOSCOPE AND IDENTIFIED THAT THE PATIENT'S BLADDER WAS PERFORATED. THE PATIENT REQUIRED OPEN SURGICAL REPAIR FOR THE BLADDER PERFORATION. THE SURGEON DOES NOT ATTRIBUTE AQUABLATION THERAPY TO THE PERFORATION. THE PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS IDENTIFIED OR REPORTED.