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 CONSISTED OF REVIEW OF DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES AND LABELLING. 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 HYDROS ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE HYDROS ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. 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: EMBOLISM. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT POST AQUABLATION THERAPY, PATIENT CODED AND WAS RESUSCITATED. THE PATIENT CODED A SECOND TIME A FEW HOURS LATER IN ICU AND PASSED AWAY. AS PER THE SURGEON, PULMONARY EMBOLISM CONTRIBUTED TO THE EVENT. AQUABLATION THERAPY COMPLETED SUCCESSFULLY. THE SURGEON STATED THAT THE OUTCOME WAS NOT RELATED TO AQUABLATION. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. 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 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.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT THE PATIENT CODED POST-AQUABLATION THERAPY. THE PATIENT WAS RESUSCITATED AND LEFT THE OPERATING ROOM (OR). THE PATIENT CODED A SECOND TIME, A FEW HOURS LATER, IN THE INTENSIVE CARE UNIT (ICU) AND PASSED AWAY. AS PER THE SURGEON, PULMONARY EMBOLISM CONTRIBUTED TO THE EVENT. THE SURGEON STATED THAT THE OUTCOME WAS NOT RELATED TO AQUABLATION. AQUABLATION THERAPY WAS COMPLETED SUCCESSFULLY. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.