MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; LARGE SUTURE CUT NEEDLE DRIVER

Model Number	471296-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was alleged that during a da vinci-assisted right hemicolectomy procedure, there was a loose grip on the needle and thread, and the needle was dropped into the patient's abdomen from the large suturecut needle driver.The needle was retrieved during the same procedure.The procedure was completed using a backup instrument.
Additional Manufacturer Narrative
The large suturecut needle driver instrument has been received; however, the failure analysis evaluation has not been completed.

• Brand Name: EndoWrist
• Common Device Name: LARGE SUTURE CUT NEEDLE DRIVER
• 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: 50192402
• Report Number: 2955842-2026-34810
• Device Sequence Number: 20361092
• Product Code: NAY
• UDI-Device Identifier: 00886874121504
• UDI-Public: (01)00886874121504(10)K12260128
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K214095
• 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
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 471296-10
• Device Catalogue Number: 471296
• Device Lot Number: K12260128 0020
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown