MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist SP; CADIERE FORCEPS

Model Number	430009-62
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted a single port (sp) cadiere forcep instrument did not move in the same direction as the surgeon¿s console hand control.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument moved in an unintended direction.The instrument was replaced with a backup instrument.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.

• Brand Name: EndoWrist SP
• Common Device Name: CADIERE FORCEPS
• 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 ; +1(408)523-2100
• MDR Report Key: 50895696
• Report Number: 2955842-2026-39921
• Device Sequence Number: 14952590
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(10)K12250320
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 430009-62
• Device Catalogue Number: 430009
• Device Lot Number: K12250320 0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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