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 THE DEVICE HISTORY RECORD (DHR) AND USER MANUAL (UM). 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. A REVIEW OF THE LOG FILES FOR THIS PROCEDURE COULD NOT BE CONDUCTED AS THEY WERE NOT PROVIDED. THREE GOOD FAITH EFFORTS (GFE) WERE MADE TO OBTAIN THE LOG FILES WITHOUT SUCCESS. IF THE LOG FILES ARE MADE AVAILABLE IN THE FUTURE, THEN THIS COMPLAINT WILL BE REOPENED TO CONDUCT SUCH A REVIEW. 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 IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT POST-AQUABLATION THERAPY, IT WAS OBSERVED THAT THE PATIENT EXPERIENCED BLADDER PERFORATION. ADDITIONAL SURGERY WAS REQUIRED TO REPAIR THE PERFORATION. ACCORDING TO THE TREATING SURGEON, THE EVENT IS NOT ATTRIBUTABLE TO AQUABLATION. THE HYDROS ROBOTIC SYSTEM'S UM LISTS BLADDER PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED AND THE DHR AND UM, THE EVENT IS CONSIDERED NOT 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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT THE PATIENT EXPERIENCED A BLADDER PERFORATION POST-AQUABLATION. ADDITIONAL SURGERY WAS REQUIRED TO REPAIR THE PERFORATION. ACCORDING TO THE TREATING SURGEON, THE EVENT IS NOT ATTRIBUTABLE TO AQUABLATION. ADDITIONAL INFORMATION REGARDING THE PATIENT'S STATUS AND WHETHER THEY HAD BEEN DISCHARGED IS UNKNOWN. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.