MAUDE Adverse Event Report: PROCEPT BioRobotics Corporation HYDROS Robotic System; Fluid Jet Removal System

Catalog Number	HY1000T
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction

• 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 ; +1(650)232-7291
• MDR Report Key: 50508236
• Report Number: 3012977056-2026-00182
• Device Sequence Number: 10087533
• Product Code: PZP
• UDI-Device Identifier: 00850055427068
• UDI-Public: 0100850055427068112505282125C02699
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male