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

Model Number	430009-52
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cadiere forceps instrument to perform failure analysis.The instrument was analyzed, and failure analysis investigations replicated and confirmed the customer-reported complaint.The instrument was found with a fully broken snake wrist control cable.There was no discoloration, corrosion, or contamination on the cable to suggest a reprocessing-related cause.The surrounding components showed no abnormal sharp edges or damage that could have contributed to the cable failure.Due to the broken cable, the instrument displayed imprecise motion when tested on an in-house system.Additional observations not reported by the site include imprecise motion in both pitch and yaw directions, with the grip tips moving as commanded but exhibiting noticeable lag or delay.The complaint was confirmed by failure analysis.The probable root cause of the broken distal snake wrist cable¿whether partially or fully fractured¿is a component failure resulting from a reduction in the cable¿s ultimate strength, likely caused by external impacts during use or reprocessing.The imprecise motion observed was directly caused by the broken wrist control cable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the cadiere forceps instrument movements were not accurate.The instrument was loose near the tip, described as "floppy".The procedure was completed, and no injuries were reported.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE 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: 23810080
• Report Number: 2955842-2025-48629
• Device Sequence Number: 9334127
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(10)S10190625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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 Model Number: 430009-52
• Device Catalogue Number: 430009
• Device Lot Number: S10190625 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2019
• 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