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

Model Number	430006-57
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The single port (sp) needle driver instrument was analyzed and found the instrument was tested twice and passed the recognition and engagement tests with no issues.The instrument moved intuitively with full range of motion in all directions.The tips opened and closed properly.Roll, grip, pitch, yaw and joggle left/right/up/down functioned without any issues.The following error was seen during log review but does not pertain to the customer reported complaint : x2 31009 ''tool sensors missing'.The instrument was fully functional.Visual inspection was performed and found no damage to the housing or tips.The housing was removed for inspection and found no internal damages.The inputs disks were manually articulated with no issues.The grip knob was able to rotate, allowing the grips to open/close without any issues.The instrument tube adapter was inspected and found no damage.No product issue was found.Additionally, the instrument was found to have a dislodged grip knob.The knob located at the top is completely removed and returned.Although the grip knob is dislodged, when placing the knob back in place, the grip knob was able to rotate and open/close the grips.The grip knob could not be securely placed and would fall off if used on the system.The complaint regarding the needle driver not twisting correctly was not confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted pyeloplasty surgical procedure, the needle driver instrument was not twisting correctly.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter to obtain additional information, however, no further details are available regarding the reported event.

• 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: 25165277
• Report Number: 2955842-2026-24981
• Device Sequence Number: 10567088
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(10)K10240404
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/13/2026

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: K10240404 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/13/2026
• 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