MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; WRISTED NEEDLE DRIVER

Model Number	478115-03
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2026
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.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis, and the complaint was confirmed.The single-site (ss) wristed needle driver instrument was analyzed and found to have a frayed pitch cable at the distal end.The cable itself was not fully broken.There was no discoloration, corrosion, or contamination found on the cable that would occur from improper reprocessing, which can reduce the material integrity.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.Additional observation(s) not reported by site: the instrument was found to have various scratches on the main tube.The scratches measured approximately 3.0 mm to 9.0 mm in length and were not axially aligned with the tube axis.Material was missing from the surface of the main tube.Part of the black plastic covering measured approximately 15.0 mm to 5.0 mm was missing.The missing material was about 150 m from the distal tip.Components adjacent to this scratched main tube do not show damage.The probable root cause of cable breakage, whether partial or full, is attributed to damage to the cable through external collisions, during use, or during reprocessing.

• Brand Name: SINGLE-SITE
• Common Device Name: WRISTED 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: 24339161
• Report Number: 2955842-2026-04163
• Device Sequence Number: 4770669
• Product Code: NAY
• UDI-Device Identifier: 00886874113752
• UDI-Public: (01)00886874113752(11)240125(10)T10240125
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 478115-03
• Device Catalogue Number: 478115
• Device Lot Number: T10240125 0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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