HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

COMPONENT CODE: 4755; THE TRUS PROBE ARM, A REUSABLE COMPONENT OF THE HYDROS ROBOTIC SYSTEM, FIXES THE TRUS PROBE AND STEPPER IN POSITION RELATIVE TO THE PATIENT. 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 THE SETUP OF THE AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, TRUS PROBE ARM JOINT BROKE AND THE ISSUE COULD NOT BE RESOLVED. AS A RESULT THE PROCEDURE HAD TO BE ABORTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

THE TRUS PROBE ARM WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A VISIBLE DAMAGE WITH THE SHELL ON JOINT 1 MISSING, EXPOSING THE INNER WORKINGS. THE RETURNED TRUS PROBE ARM WAS FUNCTIONALLY TESTED. JOINT 1 ON THE ARM MOVES EVEN WITH THE LOCK ACTUATED, RESULTING IN MOVEMENT OF THE ARM. THE REPORTED EVENT WAS CONFIRMED AND THE CAUSE OF THE ISSUE IS A MECHANICAL FAILURE BUT THE SOURCE OF THE CAUSE IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000T/SERIAL NUMBER (B)(6) AND TRUS ARM LOT NUMBER 24C04452 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 USER MANUAL UM0401-00-01 REV C STATES THE FOLLOWING ABOUT TRUS ARTICULATING ARMS IN SECTIONS 4.2.2, 4.3.1, AND 10.2: 4.3.1 AND 10.2: BE CAREFUL NOT TO DROP ARMS WHEN RETRIEVING OR MOUNTING THEM. THE ARTICULATING ARMS WEIGH APPROXIMATELY 15 LBS. EACH AND REQUIRE STRENGTH TO LIFT AND MANEUVER. 4.2.2 AND 10.2: ENSURE THE ARTICULATING ARMS ARE SECURELY MOUNTED TO THE SURGICAL TABLE BED RAIL TO PREVENT UNANTICIPATED MOVEMENT DURING THE AQUABLATION PROCEDURE. UNANTICIPATED MOVEMENT OF THE ARMS CAN CAUSE SERIOUS PATIENT INJURY. 10.2: THOROUGHLY CLEAN THE ARTICULATING ARMS WITH A LINT-FREE CLOTH MOISTENED WITH 70% IPA UNTIL ALL VISIBLE SOIL IS REMOVED. WIPE COMPLETELY DRY WITH A CLEAN LINT-FREE CLOTH. DISINFECT WITH A CLEAN LINT-FREE CLOTH WETTED WITH 70% IPA. ALLOW THE SURFACES TO COMPLETELY DRY. ALTHOUGH THIS EVENT RESULTED IN THE AQUABLATION PROCEDURE BEING ABORTED, THERE WERE NO ADVERSE HEALTH EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.