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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single site wristed needle driver 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 during a da vinci-assisted surgical procedure, the single site wristed needle driver instrument was observed to have a broken cable.The procedure was completed.There were no reports of patient injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc., (isi) followed up with the initial reporter and obtained the following additional information: the reported single site wristed needle driver instrument was available for evaluation.There was no patient injury.Photographic images of the device(s) or a video recording of the procedure were not available for isi review.Based on the additional information, the annex codes e and f were updated to e2403 and f26 respectively.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The single-site (ss) wristed needle driver instrument was analyzed and found to have a grip cable dislodged at the proximal end.The grip cable at the proximal end is causing jaws not to open and close properly.The complaint was confirmed by failure analysis.The probable root cause was attributed to a component failure.Correction(s): h8.Usage of device was updated to: initial use of device.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22984539
• Report Number: 2955842-2025-36701
• Device Sequence Number: 9549869
• Product Code: NAY
• UDI-Device Identifier: 00886874113752
• UDI-Public: (01)00886874113752(11)240404(10)T10240404
• 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,Followup
• Report Date (Section B): 02/06/2026

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: T10240404 0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/07/2025; 01/22/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/09/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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