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), TREATMENT LOG FILES AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) WAS PERFORMED, 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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE LOG FILES WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS, WHICH WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, 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: INFECTION, INCLUDING THE POTENTIAL TRANSMISSION OF BLOODBORNE PATHOGENS THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT THE PATIENT HAS HAD RECURRENT UTIS WHICH RESULTED IN UROSEPSIS. THE PATIENT WAS GIVEN ANTIBIOTICS AND DISCHARGED. THE TREATING SURGEON DID NOT ATTRIBUTE THE REPORTED EVENT TO AQUABLATION THERAPY. THE HYDROS ROBOTIC SYSTEM'S UM LISTS INFECTION AS A POTENTIAL RISK OF THE AQUABLATION PROCEDURE. BASED ON THE PROVIDED INFORMATION, 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 AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT HAD A RECURRENT URINARY TRACT INFECTION (UTI). THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE MOST RECENT INFECTION AND HAD SEPSIS. THE CAUSE OF THE SEPSIS IS UNKNOWN. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO THE AQUABLATION PROCEDURE OR THE DEVICE. THE PATIENT RECEIVED ANTIBIOTICS, WAS REPORTED TO BE DOING WELL, AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTIONS OF THE HYDROS ROBOTIC SYSTEM WERE REPORTED.