HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

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.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION WAS NOTIFIED THAT DURING PROCEDURAL SETUP AND WHILE THE PATIENT WAS UNDER ANESTHESIA IN THE OPERATING ROOM, THE WATERJET CARTRIDGE WOULD NOT FIT PROPERLY INTO THE HYDROS ROBOTIC SYSTEM PORT, PREVENTING THE LATCH FROM LOCKING PROPERLY. THE TREATING SURGEON ATTEMPTED TROUBLESHOOTING STEPS, INCLUDING REPLACING THE HANDPIECE, BUT THE ISSUE PERSISTED. AS A RESULT OF THE PROBLEM, THE TREATING SURGEON CONVERTED THE PROCEDURE TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.