HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS CURRENTLY IN THE POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), AND USER MANUAL (UM). THE HYDROS ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE HYDROS ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) WAS CONDUCTED, 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, 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: O URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT UPON REPLACING THE CATHETER, THE PATIENT'S URETHRA WAS DAMAGED BY THE NURSING STAFF. THE CATHETER WAS INFLATED INSIDE THE PATIENT'S URETHRA AND NOT IN THE BLADDER. THE TREATING SURGEON WAS NOT IMMEDIATELY NOTIFIED AND THE CATHETER COULD NOT BE RE-INSERTED. THE PATIENT RECEIVED A SUPRAPUBIC CATHETER AND REMAINED HOSPITALIZED FOR ONE WEEK BEFORE BEING DISCHARGED. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL LISTS URETHRAL DAMAGE AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE INFORMATION PROVIDED, 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 AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE NURSING STAFF HAD DAMAGED THE PATIENT'S URETHRA DURING CATHETER REPLACEMENT DUE TO CLOTTING. THE CATHETER WAS INFLATED WITHIN THE PATIENT'S URETHRA RATHER THAN WITHIN THE BLADDER. THE TREATING SURGEON WAS NOT IMMEDIATELY NOTIFIED, AND THE CATHETER COULD NOT BE RE-INSERTED. THE PATIENT UNDERWENT PLACEMENT OF A SUPRAPUBIC CATHETER AND WAS HOSPITALIZED FOR 1 WEEK BEFORE DISCHARGE. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.