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

Model Number	430100-02
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors instrument was analyzed and found to have a dislodged crimp.A visual inspection revealed that the instrument had a dislodged crimp.The wrist constraint crimp was found to be dislodged at the distal end, resulting in imprecise instrument motion.Due to the dislodged crimp, the instrument is unable to straighten the wrist.There is no damage to the main tube, joggle tube, housing, or grip tips.The release buttons and grip knob are functional.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 3.2mm x 1.7mm, was not returned with the instrument.The complaint was confirmed by failure analysis.The probable root cause is attributed to the instrument experiencing more load than anticipated.The cable crimp can become dislodged due to back-driving of wrist and joggle joints with the insertion axis.Applying excessive force on the instrument shaft and/or tip during handling, insertion, usage (overloading), or removal can also cause the crimp to dislodge.
Event or Problem Description
It was reported that prior to start of da vinci-assisted surgical procedure, the monopolar curved scissors instrument was found to have protruding wire and was bent.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the damage was identified prior to the start of the procedure during preparation.No fragments fell into the patient, and all observed damage or material loss occurred outside of surgery.Additionally, there were no instances of the patient returning to the hospital due to complications associated with the retention of foreign material.

• 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: 25074426
• Report Number: 2955842-2026-23710
• Device Sequence Number: 10306439
• Product Code: NAY
• UDI-Device Identifier: 00886874123454
• UDI-Public: (01)00886874123454(11)251022(10)H10251022
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K241814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 430100-02
• Device Catalogue Number: 430100
• Device Lot Number: H10251022 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• 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