HYDROS 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 POST-AQUABLATION, THE PATIENT EXPERIENCED RECTAL INJURY. IT WAS ALSO NOTED THAT, DESPITE THE PATIENT HAVING A J-POUCH, THE PATIENT UNDERSTOOD THE INHERENT RISKS AND WAS STILL DETERMINED TO UNDERGO AQUABLATION THERAPY. ACCORDING TO THE TREATING SURGEON, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT STATUS AND WHETHER THEY HAVE BEEN DISCHARGED REMAIN UNKNOWN DESPITE MULTIPLE FOLLOW-UPS. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.

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) FOR HY1000T/SERIAL NUMBER (B)(6) WAS PERFORMED, 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. A REVIEW OF THE LOG FILES FOR THIS PROCEDURE COULD NOT BE CONDUCTED AS THEY WERE NOT PROVIDED. EFFORTS WERE MADE TO OBTAIN THE LOG FILES WITHOUT SUCCESS. IF THE LOG FILES ARE MADE AVAILABLE IN THE FUTURE, THEN THIS COMPLAINT WILL BE REOPENED TO CONDUCT SUCH A REVIEW. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, REV. C, WAS REVIEWED. 4.2.3 WARNINGS: PROCEDURE: DO NOT USE EXCESSIVE FORCE WHEN MANIPULATING THE TRUS PROBE TO AVOID RECTAL INJURY. 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. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECTAL INJURY. IT WAS ALSO NOTED THAT, DESPITE THE PATIENT HAVING A J-POUCH, THE PATIENT UNDERSTOOD THE INHERENT RISKS AND WAS STILL DETERMINED TO UNDERGO AQUABLATION THERAPY. ACCORDING TO THE TREATING SURGEON, THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT STATUS AND WHETHER THEY HAVE BEEN DISCHARGED REMAIN UNKNOWN DESPITE MULTIPLE FOLLOW-UPS. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) LISTS RECTAL PERFORATION AND RECTAL INJURY AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, 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.