MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PROGRASP FORCEPS

Model Number	470093-11
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The prograsp forceps instrument was analyzed and found to have a missing clevis pin from the distal clevis likely causing issue reported by the customer.The missing pin was not returned with the instrument.Components surrounding the missing clevis pin did not exhibit damage that would have contributed to the clevis pin issue.The complaint regarding the instrument jaws could not be controlled by the main blade was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy (without lymphadenectomy) surgical procedure, the prograsp forceps instrument jaws were not controlled by the main blade.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred while the surgeon¿s head was inside the surgeon console¿s high resolution stereo viewer and during active instrument manipulation.Instrument movements matched the surgeon¿s intended direction and scale, and timing was appropriate without delay or lag.The instrument was not static, there were no visible broken cables at the instrument wrist, and no injury was reported to the patient.

• Brand Name: ENDOWRIST
• Common Device Name: PROGRASP FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 24284657
• Report Number: 2955842-2026-03635
• Device Sequence Number: 8365703
• Product Code: NAY
• UDI-Device Identifier: 00886874112267
• UDI-Public: (01)00886874112267(11)241010(10)K10241010(91)0001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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 Model Number: 470093-11
• Device Catalogue Number: 470093
• Device Lot Number: K10241010 0207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown