HYDROS ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE PATIENT'S VITALS DROPPED. IMMEDIATE SUPPORT WAS CALLED IN AS PATIENT WAS RAPIDLY DECLINING. PULMONARY EMBOLISM (PE) WAS SUSPECTED DURING INITIAL ASSESSMENT, BUT LATER RULED OUT. PATIENT RECEIVED COMPUTED TOMOGRAPHY (CT) IMAGING. AS PER THE TREATING SURGEON, THE PATIENT DID NOT SUFFER A PULMONARY EMBOLISM (PE) OR MYOCARDIAL INFARCTION (MI). THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. THE AQUABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS DISCHARGED THAT SAME DAY. THE SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION CONSISTS OF REVIEW OF DEVICE HISTORY RECORD (DHR), LOG FILES AND LABELLING. 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 LOG FILES OF THIS EVENT WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS AND WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM USER MANUAL, UM0401-00-01 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 ANESTHESIA RISK. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION THERAPY/DEVICE. PATIENT ONLY RECEIVED A COMPUTED TOMOGRAPHY (CT) IMAGING, NO OTHER MEDICAL INTERVENTIONS WAS NECESSARY. IT WAS REPORTED THAT AQUABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SAME DAY. ROOT CAUSE OF THIS EVENT IS UNKNOWN. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. BASED ON THE INFORMATION OBTAINED THROUGH THE TREATING SURGEON PLUS A REVIEW OF THE TREATMENT LOG FILES, 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.