HYDROS ROBOTIC SYSTEM
Received Apr 1, 2026 · Event occurred Mar 5, 2026
Report 3012977056-2026-00061 · MDR key 24756177
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Myocardial Infarction
- Embolism/Embolus
Narrative
Additional Manufacturer Narrative
THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS CURRENTLY IN THE 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 HY1000/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 FILE IS NOT APPLICABLE AS THE LOGS WILL NOT CAPTURE ANY INFORMATION RELATED TO THE REPORTED EVENT. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. 3. CONTRAINDICATIONS DO NOT USE THE HYDROS ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS CURRENTLY IN THE POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2026 - THE DAY AFTER AQUABLATION THERAPY. THE TREATING SURGEON STATED THAT THE PATIENT HAD PRIOR ORTHOPEDIC KNEE REPLACEMENT AND PRESENTED VENOUS ISSUES. IT WAS CONFIRMED THAT THE CAUSE OF DEATH WAS UNRELATED TO AQUABLATION PROCEDURE AND THAT THE CAUSE OF DEATH WAS A PULMONARY EMBOLISM FROM A PELVIC DEEP VEIN THROMBOSIS WITH MYOCARDIAL INFARCTION. BASED ON THE INFORMATION PROVIDED, PLUS A REVIEW OF THE 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.
Description of Event or Problem
A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT A PATIENT'S DEATH OCCURRED ON (B)(6) 2026, THE DAY AFTER AQUABLATION THERAPY. THE TREATING SURGEON CONFIRMED THE CAUSE OF DEATH WAS UNRELATED TO THE AQUABLATION PROCEDURE AND ATTRIBUTED IT TO PULMONARY EMBOLISM AND PELVIC DEEP VEIN THROMBOSIS WITH MYOCARDIAL INFARCTION. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.