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

Model Number	471006-13
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The large needle driver instrument has been received; however, the failure analysis evaluation has not been completed at this time.
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy, fraying was observed on the tip of the large needle driver cable.No fragment fell into the patient's anatomy during the procedure.X-ray imaging was initially reported to have been obtained; however, this could not be confirmed, and no additional details are available regarding whether imaging was performed or the rationale for obtaining it.No patient injury was reported.The procedure was completed.There was no report of the patient returning due to post-surgical complications.

• Brand Name: EndoWrist
• Common Device Name: LARGE 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: 50541611
• Report Number: 2955842-2026-37462
• Device Sequence Number: 21371337
• Product Code: NAY
• UDI-Device Identifier: 00886874119754
• UDI-Public: (01)00886874119754(10)K14251204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 471006-13
• Device Catalogue Number: 471006
• Device Lot Number: K14251204 0428
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/04/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2024-09-C
• 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