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

Model Number	430006-57
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has issued a return material authorization (rma) to have the device returned.However, isi has not received the instrument involved with the alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted oophorectomy surgical procedure, the customer contacted intuitive surgical, inc.(isi) technical service engineer (tse) and reported the single port (sp) needle driver did not move in the desired direction.The issue was not resolved even after re-attaching the device.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) obtained the additional information: the issue occurred while the surgeon's head was inside the surgeon console¿s high resolution stereo viewer and was attempting to manipulate the instruments.There were no external collisions.The issue was persistent.The action being taken was suturing.The instrument moved in the wrong direction.The surgeon said that when extending to the right, the movement was diagonal or moved less than expected.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 6mm needle driver instrument for failure analysis investigation.The instrument was analyzed and the complaint was not confirmed by failure analysis.The instrument was tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grip tips opened and closed properly.The instrument was retested and passed on both attempts.The needle driver test which included driving a needle through a foam pad, passed with no problems.The instrument was fully functional.Visual inspection was performed and found no damage to the housing.The housing was removed for inspection and found no internal damages.The input disks were manually articulated with no issues.The grip knob was able to rotate, allowing the grips to open/close without any issues.No product issue was found.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 23709931
• Report Number: 2955842-2025-47190
• Device Sequence Number: 18790434
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(11)230428(10)K10230427
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2026

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: 430006-57
• Device Catalogue Number: 430006
• Device Lot Number: K10230427 0005
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 12/31/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/12/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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