MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CAUTERY INSTRUMENT

Model Number	430007-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar cautery instrument was analyzed and found to have a broken tube adapter.This component was located at the distal end of the instrument and serves as the interface between the instrument and the user installed tip accessory.The instrument tube adapter appeared to be smashed and broken.Due to the broken instrument tube adapter, the user tip accessory could not be installed.The inputs were manually articulated and passed.The complaint was confirmed by failure analysis.The probable root cause of a damaged tube adapter is attributed to either tip accessory installation issues or damage during use.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that prior to a da vinci-assisted surgical procedure, the tip of the 6mm monopolar cautery instrument was unable to attach.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CAUTERY INSTRUMENT
• 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: 24636057
• Report Number: 2955842-2026-16768
• Device Sequence Number: 8596671
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(11)250109(10)K10250109
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/18/2026

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: 430007-62
• Device Catalogue Number: 430007
• Device Lot Number: K10250109 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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