HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE HANDPIECE WAS RETURNED FOR INVESTIGATION. THE EDGE CARD OF THE HANDPIECE WAS VIEWED UNDER THE MICROSCOPE, AND NO CONTAMINATION WAS OBSERVED. NO OTHER DAMAGES AND ANOMALIES WERE OBSERVED. THE HANDPIECE WAS CONNECTED TO THE FAILURE ANALYSIS HYDROS ROBOTIC SYSTEM, SUCCESSFULLY ESTABLISHING THE CONNECTION. FURTHER TESTING REVEALED THAT THE CMOS COULD NOT ESTABLISH A CONNECTION. THE LED BEGAN TO FLICKER. RESISTANCE VALUES WERE MEASURED, AND NO ABNORMAL READINGS WERE OBSERVED. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS FLUID INGRESS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HYDROS HANDPIECE LOT NUMBER 25C02180 AND HY1000T/ 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. LOG FILES FOR THIS EVENT WERE REVIEWED. THE SYSTEM TRIGGERED "E917 - CYSTOSCOPE NOT DETECTED BY SYSTEM" ERROR CONFIRMING THE REPORTED FAILURE MODE. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. TABLE 5 ERROR MESSAGES: E917: RECONNECT COMPONENT: 1. RELEASE FOOT PEDAL. 2. CHECK STATUS PANEL FOR SOURCE OF ISSUES. 3. RECONNECT OR REPLACE COMPONENT AS NEEDED UNTIL STATUS BECOMES GREEN. 4. CLICK OK TO CLEAR ALERT; MAY REQUIRE REALIGNMENT AND REPLANNING IF ISSUE PERSISTS, CALL PROCEPT BIOROBOTICS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE DURING AQUABLATION THERAPY THAT THE HYDROS ROBOTIC SYSTEM GENERATED AN "E917 - CYSTOSCOPE NOT DETECTED BY SYSTEM" ERROR. DESPITE TROUBLESHOOTING ATTEMPTS AND REPLACING THE HYDROS HANDPIECE, THE ISSUES PERSISTED. THE REPORTED EVENT RESULTED IN THE PROCEDURE BEING ABORTED WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.