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 DEVICE HISTORY RECORD (DHR), AND USER MANUAL (UM). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR HY1000-US/SERIAL NUMBER (B)(6), 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 SYSTEM MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE LOG FILES WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS, WHICH WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, REV. C, WAS REVIEWED. 4.2.3 WARNINGS: PROCEDURE: AVOID APPLYING EXCESSIVE COMPRESSION TO THE PROSTATE. EXCESSIVE COMPRESSION CAN CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE THE FOLLOWING, SOME OF WHICH MAY LEAD TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: RECTAL INCONTINENCE OR RECTAL INJURY, INCLUDING PERFORATION. BLADDER OR PROSTATE CAPSULE PERFORATION. IT WAS REPORTED THAT DURING FOCAL BLADDER NECK CAUTERY, A RECTAL AND BLADDER PERFORATION OCCURRED WITH THE RESECTOSCOPE. THE ANGLED TRUS PROBE WAS MISTAKENLY IDENTIFIED AS A MEDIAN LOBE DURING HEMOSTASIS AT THE BLADDER OUTLET. THE SURGEON PUT IN A RECTAL TUBE AND PLACED A SMALL STICH INSIDE OF THE RECTUM WHERE THE PERFORATION OCCURRED. THE PATIENT SPENT A COUPLE OF EXTRA DAYS IN THE HOSPITAL AS A RESULT OF THIS EVENT. THE PATIENT IS DOING WELL AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE TREATING SURGEON DOES NOT ATTRIBUTE AQUABLATION AS THE CAUSE FOR THIS EVENT. THE HYDROS ROBOTIC SYSTEM'S UM LISTS BLADDER AND RECTAL PERFORATION AS POTENTIAL RISKS OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE DHR, AND UM, 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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING FOCAL BLADDER NECK CAUTERY, A RECTAL AND BLADDER PERFORATION OCCURRED WITH THE RESECTOSCOPE. THE TREATING SURGEON PUT IN A RECTAL TUBE AND PLACED A SMALL STITCH INSIDE THE RECTUM WHERE THE PERFORATION OCCURRED. THE PATIENT SPENT A COUPLE OF EXTRA DAYS IN THE HOSPITAL AS A RESULT OF THIS EVENT. THE PATIENT IS DOING WELL AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.