MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CURVED SCISSORS

Model Number	430004-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, the tip of monopolar curved scissors was found to be broken.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations did confirm and replicate the customer complaint "broken tip".The instrument was found to have a broken tube adapter.This component is located at the distal end of the instrument and serves as the interface between the instrument and the user installed tip accessory.The broken piece, measuring approximately 1.8mm x 2.6mm was not return with the instrument.Visual inspection was performed and there was no damage to the snake wrist cables, housing and shaft.The probable root cause of a damaged tube adapter is attributed to either tip accessory installation issues or damage during use.This issue can be resolved by using an alternate instrument to complete the procedure.

• Brand Name: ENDOWRIST SP
• Common Device Name: MONOPOLAR CURVED SCISSORS
• 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: 24838111
• Report Number: 2955842-2026-21081
• Device Sequence Number: 17678700
• Product Code: NAY
• UDI-Device Identifier: 00886874114285
• UDI-Public: (01)00886874114285(11)250729(10)K10250729
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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,Followup
• Report Date (Section B): 05/11/2026

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: 430004-62
• Device Catalogue Number: 430004
• Device Lot Number: K10250729 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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