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 OF THIS EVENT CONSISTED OF A REVIEW OF THE INFORMATION PROVIDED, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND PROCEPT'S RISK DOCUMENTATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) WAS CONDUCTED, 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 USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. ALTHOUGH THE HYDROS ROBOTIC SYSTEM'S LABELING DOES NOT SPECIFICALLY MENTION DAMAGE TO URETERAL ORIFICES, PROCEPT'S RISK MANAGEMENT DOCUMENTATION INCLUDES DAMAGE TO URETERAL ORIFICES AS A CLINICAL EFFECT OF AQUABLATION THERAPY. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT DURING FOCAL BLADDER NECK CAUTERY (FBNC), THE TREATING SURGEON INADVERTENTLY RESECTED OVER THE PATIENT'S LEFT URETERAL ORIFICE (UO). IT IS UNKNOWN WHETHER THERE WAS ANY MEDICAL INTERVENTION OR ADDITIONAL SURGERY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER INFORMATION COULD NOT BE RETRIEVED REGARDING THE EVENT AND PATIENT STATUS. ALTHOUGH THE HYDROS ROBOTIC SYSTEM'S LABELING DOES NOT SPECIFICALLY MENTION DAMAGE TO URETERAL ORIFICES, PROCEPT'S RISK MANAGEMENT DOCUMENTATION INCLUDES DAMAGE TO URETERAL ORIFICES AS A CLINICAL EFFECT OF AQUABLATION THERAPY. BASED ON THE INFORMATION RECEIVED AND A REVIEW OF THE UM AND RISK DOCUMENTATION, 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 SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING FOCAL BLADDER NECK CAUTERY (FBNC), THE TREATING SURGEON INADVERTENTLY RESECTED OVER THE PATIENT'S LEFT URETERAL ORIFICE (UO). THE PATIENT RECEIVED A CATHETER AND IT IS UNKNOWN WHETHER THERE WAS ANY MEDICAL INTERVENTION OR ADDITIONAL SURGERY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER INFORMATION COULD NOT BE RETRIEVED REGARDING THE EVENT AND PATIENT STATUS. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.