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

Catalog Number	HY1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury

• 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
• MDR Report Key: 50566508
• Report Number: 3012977056-2026-00177
• Device Sequence Number: 18619153
• Product Code: PZP
• UDI-Device Identifier: 00850055427068
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: HY1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male