MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION HYDROS ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number	HY1000T
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A male patient underwent aquablation therapy to treat symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during aquablation therapy and while the patient was in the operating room under anesthesia, the handpiece on the hydros robotic system generated error code ¿e917 ¿ cystoscope sensor tip disconnected¿.The surgeon opted to switch to an alternate handpiece for the hydros robotic system; however, the same error code persisted.A third handpiece was subsequently opened and used, allowing the procedure to be completed without further issues.The reported event caused a surgical delay of over 20 minutes.There were no adverse health consequences to the patient due to this 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.
Additional Manufacturer Narrative
The hydros handpiece was not returned for investigation.Three (3) good faith efforts were made by procept to retrieve the hydros handpiece without success.The treatment log files were reviewed and found occurrences of e917 errors.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 hy1000/serial number (b)(6) and hydros handpiece/lot number 24c03673 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 robotic system's user manual, um0401-00-01, rev.B 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.

• Brand Name: HYDROS ROBOTIC SYSTEM
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr; san jose, CA 95134 ; 6502327291
• MDR Report Key: 21453861
• Report Number: 3012977056-2025-00056
• Device Sequence Number: 12585329
• Product Code: PZP
• UDI-Device Identifier: 00850055427051
• UDI-Public: 0100850055427051172503311024C03673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HY1000T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male