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 DEVICE HISTORY RECORD (DHR), AND USER MANUAL (UM). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HY1000T-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 USER MANUAL, UM0401-00 REV C WAS REVIEWED AND STATES THE FOLLOWING: 3. CONTRAINDICATIONS DO NOT USE THE HYDROS ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. 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 EMBOLISM THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT DURING HEMOSTASIS, THE PATIENT¿S BLOOD PRESSURE DROPPED AND A CODE BLUE WAS CALLED. RESUSCITATION EFFORTS WERE INITIATED, BUT THE PATIENT WAS PRONOUNCED DECEASED. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. THE TREATING SURGEON BELIEVES IT WAS DUE TO A PULMONARY EMBOLISM (PE) AND IS UNRELATED TO THE PERFORMANCE OF THE HYDROS ROBOTIC SYSTEM OR AQUABLATION THERAPY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL LISTS EMBOLISM AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE INFORMATION OBTAINED THROUGH THE TREATING SURGEON PLUS A REVIEW OF THE DHR, AND LABELING, 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 DURING HEMOSTASIS, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A CODE BLUE WAS CALLED. RESUSCITATION EFFORTS WERE INITIATED, BUT THE PATIENT WAS PRONOUNCED DECEASED. IT WAS REPORTED THAT AN AUTOPSY WAS OFFERED TO THE RELATIVES, BUT IT IS NOT KNOWN IF IT WAS PERFORMED. THE TREATING SURGEON DOES NOT BELIEVE THE EVENT IS RELATED TO AQUABLATION THERAPY AND SUSPECTS A PULMONARY EMBOLISM. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.