MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE NEEDLE DRIVER

Model Number	420006-06
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that there was a broken cable with a da vinci product.The customer reported event has no report of patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The large needle driver instrument was analyzed and found to have two broken grip cables at the proximal end within the housing.The grip cables were fully broken at the clamping pulley of both grip input disk.This failure causes the grip cables to appear loose in the distal end.There was no discoloration, corrosion, or contamination on the cable to suggest improper reprocessing as a contributing factor.Further inspection found a broken pitch cable, dislodged main tube holder and main tube and dislodged proximal clevis.Additional observation(s) related to the customer's complaint: the instrument was found to have one of the pitch cables broken at the proximal end in the housing.The pitch cable was broken at clamping pulley.The clamping pulley did exhibit signs of residue that would have contributed to the broken cable.Components adjacent to this broken pitch cable show damage.The main tube holder and main tube are dislodged, the proximal clevis was found to be dislodged, and the grip cables are broken.The instrument was found to have a dislodged main tube holder from the proximal end housing.The tube holder is not in its original position.This causes the main tube to move up and down freely.Components adjacent to this dislodged main tube holder show damage which may indicate potential mishandling/misuse.The main tube is dislodged, the proximal clevis was found to be dislodged, and the grip and pitch cables are broken.The instrument was found to have a dislodged main tube from the proximal end housing and from the proximal clevis on the distal end.Components adjacent to this dislodged main tube show damage which may indicate potential mishandling/misuse.The main tube holder is dislodged, the proximal clevis was found to be dislodged, and the grip and pitch cables are broken.The instrument was found to have a dislodged proximal clevis.Clevis does not show abrasions or scratches on the outer surface.Components adjacent to the dislodged clevis show damage which may indicate potential mishandling/misuse.The main tube holder and main tube are dislodged, and the grip and pitch cables are broken.Common causes of broken - proximal instrument grip cables are attributed to damage to the cable during use or during reprocessing.The root cause is attributed to a dislodged main tube holder.Common causes of the failure mode dislodged instrument proximal clevis are attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Instrument collisions with other hand-held instrumentation or instrument driven outside the field of view can also cause damage to the instrument proximal clevis.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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 ; 4085232100
• MDR Report Key: 24088455
• Report Number: 2955842-2026-01472
• Device Sequence Number: 9713271
• Product Code: NAY
• UDI-Device Identifier: 00886874111192
• UDI-Public: (01)00886874111192(10)M10121108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• 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,Followup
• Report Date (Section B): 05/18/2026

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: 420006-06
• Device Catalogue Number: 420006
• Device Lot Number: M10121108 415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2012
• 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