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	Insufficient Information (4580)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis, and the complaint was confirmed.The single-port (sp) monopolar cautery instrument was analyzed, and the proximal clevis was found to have workmanship issues due to the clevis being detached.Visual inspection at the welds showed that 1 of the 2 welds were missing.The missing weld causes the tip to be less stable and likely caused the tip to be dislodged.No external damages were seen on the housing.The housing was removed and found no internal damages.All input disks articulated without any issues.The probable root cause of the detached clevis findings was attributed to manufacturing issues.
Event or Problem Description
It was reported that during central processing, the single-port (sp) monopolar cautery instrument had a broken tip.There was no report of patient involvement.

• 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: 24014540
• Report Number: 2955842-2026-00526
• Device Sequence Number: 18789319
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(11)240926(10)U10240926(91)0004
• 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): 01/08/2026

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: U10240926 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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