MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; FORCE BIPOLAR

Model Number	471405-06
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm force bipolar instrument could not be rotated properly.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The 8mm force bipolar instrument was analyzed; however, the findings did not replicate or confirm the customer reported event.Manual inspection confirmed the instrument fully met all criteria, passed recognition and engagement tests on an in-house system, and demonstrated full range of motion in all directions.The grip tips opened and closed properly, and the instrument passed grip testing, energy delivery testing in various grip orientations, and electrical continuity testing.The instrument was fully functional.Additionally, the force bipolar instrument was found to have a broken grip tang at the middle of the grip, with an approximately 5mm x 2mm fragment confirmed to have detached from the instrument.The broken piece was not returned with the instrument.No further damage or abnormalities were identified.

• Brand Name: EndoWrist
• Common Device Name: FORCE BIPOLAR
• 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 ; +1(408)523-2100
• MDR Report Key: 50949279
• Report Number: 2955842-2026-40294
• Device Sequence Number: 9624482
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K13250807 0133
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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: 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