AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT EXPERIENCED CARDIAC ARREST, FOLLOWED BY DEATH. THE CAUSE OF DEATH REMAINS UNKNOWN, AS THE TREATING SURGEON DID NOT PROVIDE ANY FURTHER DETAILS DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION SUCH AS THE CAUSE OF DEATH AND THE RELATIONSHIP TO THE DEVICE OR PROCEDURE. THE DATE OF DEATH IS ALSO UNKNOWN. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. IT WAS REPORTED THAT PATIENT EXPERIENCED CARDIAC ARREST, FOLLOWED BY DEATH. THE CAUSE OF DEATH REMAINS UNKNOWN, AS THE TREATING SURGEON DID NOT PROVIDE ANY FURTHER DETAILS DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION SUCH AS CAUSE OF DEATH AND RELATIONSHIP TO THE DEVICE OR PROCEDURE. SHALL NEW INFORMATION BECOMES AVAILABLE IN THE FUTURE, THEN FURTHER INVESTIGATION WILL BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B/SERIAL NUMBER: (B)(6) WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCE'S, 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'S TREATMENT LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE AND INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. 3. CONTRAINDICATIONS DO NOT USE THE AQUABEAM ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.