HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE HYDROS HANDPIECE (HP) WAS NOT RETURNED FOR INVESTIGATION. THREE (3) GOOD FAITH EFFORTS WERE MADE BY PROCEPT TO RETRIEVE THE PRODUCT WITHOUT SUCCESS. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE ESTABLISHED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 25C04022 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. A REVIEW OF THE TREATMENT LOGS FILES CONFIRMED E432 AND E5 ERRORS. HP WAS NOT RETURNED PER CASE DETAILS. LOG REVIEW CONFIRMED E432 AND E5 ERRORS. ADDITIONALLY, AFTER THE COMPLAINT EVENT, AS OF INVESTIGATION COMPLETION DATE, MULTIPLE PROCEDURES HAVE BEEN COMPLETED AT THIS HOSPITAL SUCCESSFULLY, INDICATING NO TOWER LEVEL ISSUES. ROOT CAUSE IS UNDETERMINABLE AS THE ISSUE CANNOT BE INVESTIGATED FURTHER DUE TO UNAVAILABILITY OF DEVICE. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED FOR INVESTIGATION.

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 AQUABLATION THERAPY, THE HYDROS ROBOTIC SYSTEM DISPLAYED ERROR E05 ¿ CONSOLE ERROR AND ERROR E432 COMMUNICATION ERROR REPEATEDLY. THE CUSTOMER ATTEMPTED TO CLEAR THE FAULT, BUT THE ERRORS PERSISTED. DUE TO THE INABILITY TO RESOLVE THE ISSUE, THE PROCEDURE WAS CUT SHORT TO 1.5 TREATMENT PASSES, AND THE TREATING SURGEON PROCEEDED WITH FOCAL BLADDER NECK CAUTERY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT FROM THIS EVENT.