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 BECAME AWARE THAT, DURING AQUABLATION THERAPY, THE PHYSICIAN ADJUSTED THE HYDROS HANDPIECE TO A FLAT, PARALLEL POSITION RELATIVE TO THE PROSTATE WHEN BOTH THE PHYSICIAN AND THE CLINICAL REPRESENTATIVE HEARD A CRACKING SOUND FROM THE HANDPIECE. THE PHYSICIAN CONTINUED REPOSITIONING THE DEVICE. SUBSEQUENTLY, HYDROS CYSTOSCOPIC VISUALIZATION WAS LOST, AND A RED ¿X¿ ERROR INDICATOR APPEARED ON THE SYSTEM SCREEN. THE SCOPE CARRIAGE WAS ROLLED BACK, AND THE HANDPIECE WAS REMOVED FROM THE PATIENT. DUE TO A MALFUNCTION OF THE HYDROS HANDPIECE, THE SURGEON CONVERTED THE PROCEDURE TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.