AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLADDER PERFORATION. THE TREATING SURGEON REPORTED THAT THE AQUABEAM ROBOTIC SYSTEM WAS NOT ASPIRATING AS INTENDED. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING WHETHER FURTHER MEDICAL INTERVENTION OR SURGICAL REPAIR WAS REQUIRED TO MANAGE THE PERFORATION. THE PATIENT REPORTEDLY REMAINED HOSPITALIZED FOR AN ADDITIONAL 2¿3 DAYS FOR CLOSE MONITORING AND WAS MANAGED WITH A CATHETER DURING THAT TIME.

Additional Manufacturer Narrative

COMPONENT CODE = 4756 - AQUABEAM CONSOLE, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM. ROOT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN PROCESS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.