MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; NEEDLE DRIVER

Model Number	430006-52
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The needle driver instrument was analyzed, and the complaint was not confirmed by failure analysis.The instrument was evaluated on an in-house system and successfully passed recognition and engagement testing.It moved intuitively with a full range of motion in all directions, the grip tips opened and closed properly, and the instrument was fully functional.The probable root cause cannot be determined based on the information provided and failure analysis results.The reported event was not confirmed as failure analysis found no functional issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the needle driver instrument would not follow the direction the surgeon was attempting to maneuver.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument did not remain static and moved in the opposite direction of the intended command; when movement to the right was intended, the instrument instead moved to the left.There was no delay or shakiness observed, but the movement was persistently in the wrong direction.The timing of instrument movement was appropriate, with no lag; however, the issue remained consistent throughout use.The problem was resolved by changing the arm, though details such as the lot number of the drape were unavailable, as it was disposed of.There were no injuries to the patient.

• Brand Name: ENDOWRIST SP
• Common Device Name: 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: 24329336
• Report Number: 2955842-2026-03955
• Device Sequence Number: 13211265
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(10)S10210819
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 430006-52
• Device Catalogue Number: 430006
• Device Lot Number: S10210819 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American