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

Model Number	430006-62
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the instrument; however, intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the single port (sp) needle driver instrument had a piece broke off.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 damage to the needle driver occurred outside the surgical field, when it became stuck to the sp patient cart due to drape interference and was damaged during removal.No fragments were introduced into the patient, and no post-surgical complications have been reported.The damaged portion includes the working end that would normally go inside the patient, but no patient contact occurred during this event.The patient has not returned to the hospital with any such complications related to this issue.No images or video recordings are available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single port (sp) needle drive instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have the roll input disk completely broken off.The disk was not returned with the instrument.No other components near the broken input were damaged.The probable root cause is attributed to use and reprocessing conditions.The input disk can be susceptible to chemical or thermal stresses, which can result in the appearance of cracks.Under repeated or prolonged chemical or thermal exposure cycles, these cracks can propagate into larger cracks and may cause the input disk to break and separate from the instrument.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The single port (sp) needle drive instrument was transferred to supplier engineering to inspect the broken input disk.The engineer mentioned that the broken input appeared to potentially be caused by "mishandling during system installation or cleaning." there were no additional findings.

• 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: 24102291
• Report Number: 2955842-2026-01574
• Device Sequence Number: 21392099
• Product Code: NAY
• UDI-Device Identifier: 00886874114308
• UDI-Public: (01)00886874114308(11)250129(10)K10250129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 04/06/2026

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: 430006-62
• Device Catalogue Number: 430006
• Device Lot Number: K10250129 0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 03/10/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/23/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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