HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM HANDPIECE (HP) WAS NOT RETURNED FOR INVESTIGATION. THREE (3) GOOD FAITH EFFORTS WERE MADE BY PROCEPT TO RETRIEVE THE AQUABEAM HP 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 25C05421 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 TREATMENT SESSION LOG FILE WERE REVIEWED AND CONFIRMED THE OCCURRENCE OF ERROR E251 (Z ENCODER SPEED WAS LESS THAN 80% OF THE DESIRED SPEED FOR OVER 10MS) IN THE TREATMENT STAGE. THE HP WAS NOT RETURNED AFTER FOLLOW UPS. THE APPLICATION LOG FILE REVIEW CONFIRMED THE OCCURRENCE OF E251 IN TREATMENT STAGE. ROOT CAUSE IS UNDETERMINABLE AS THE ISSUE CANNOT BE INVESTIGATED FURTHER DUE TO UNAVAILABILITY OF DEVICE. 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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING THE FIRST TREATMENT PASS, THE HYDROS ROBOTIC SYSTEM DISPLAYED ERROR E251 (Z ENCODER SPEED WAS LESS THAN 80% OF THE DESIRED SPEED FOR OVER 10MS). THE TREATING SURGEON TRIED TO MANUALLY MOVE THE WATERJET, BUT THE ERROR PERSISTED. DUE TO THE INABILITY TO RESOLVE THE ISSUE, THE TREATING SURGEON DECIDED TO ABORT THE PROCEDURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.