MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CURVED BIPOLAR DISSECTOR

Model Number	471344-19
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The curved bipolar dissector was analyzed and found to have thermal damage to the yaw pulley.The yaw pulley had charring and/or localized melting on the outer surface of one bipolar yaw pulley at the base of the grip.As a result of the damage, a section of the active electrode (grip) is exposed that would not normally be exposed.The instrument passed the electrical continuity test.The complaint was confirmed by failure analysis.The probable root cause of thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, the curved bipolar dissector instrument had surface damage.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: CURVED BIPOLAR DISSECTOR
• 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: 24866656
• Report Number: 2955842-2026-21327
• Device Sequence Number: 10493737
• Product Code: NAY
• UDI-Device Identifier: 00886874121511
• UDI-Public: (01)00886874121511(11)250220(10)K10250220
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K214095
• 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): 04/13/2026

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: 471344-19
• Device Catalogue Number: 471344
• Device Lot Number: K10250220 0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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