AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM 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 INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-D/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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE (IFU), SJ-IFU0101-00 REV C, WAS REVIEWED AND STATES THE FOLLOWING: 3. CONTRAINDICATIONS DO NOT USE THE AQUABEAM 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: EMBOLISM. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING THE SECOND PASS OF AQUABLATION TREATMENT, THE PATIENT HAD A CARDIAC ARREST. A CODE BLUE WAS CALLED TO STABILIZE THE PATIENT. THE TREATING SURGEON WAS ABLE TO COMPLETE HEMOSTASIS SAFELY. THE PATIENT HAD A PULMONARY EMBOLISM. AFTER SURGERY, THEY WERE TRANSPORTED TO THE ICU. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION THERAPY. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU) LIST EMBOLISM AS POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE EVENT DETAILS, DHR, AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE-RELATED.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING THE SECOND TREATMENT PASS, THE PATIENT HAD A CARDIAC ARREST. A CODE BLUE WAS CALLED TO STABILIZE THE PATIENT. THE TREATING SURGEON SUCCESSFULLY ACHIEVED HEMOSTASIS. IT WAS DETERMINED THAT THE PATIENT HAD A PULMONARY EMBOLISM. THE PATIENT WAS THEN TAKEN TO THE INTENSIVE CARE UNIT (ICU) AS A RESULT OF THIS EVENT. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.