MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MEDIUM-LARGE CLIP APPLIER

Model Number	430005-57
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
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.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the surgeon used a robot sp medium-large clip applier for vessel ligation.The surgeon mentioned that the movement of the instrument seemed a bit awkward.When attempting vessel ligation, the clip did not attach properly and fell off.Another attempt was made to attach the clip for ligation, but it failed again.The surgeon requested to check if the instrument was faulty.Upon detaching the instrument from the robot and removing the instrument sheath, it was discovered that one wire was broken.The surgery was completed using a backup robot instrument of the same type.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) obtained the following information: issue occurred while the surgeon attempted to clamp on a vessel or tissue bundle.The movement of the instrument seemed a bit awkward.Customer used back-up instrument to resolve the issue.Instrument is available for return.No photos or videos are available for review.No injury to patient.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm medium-large clip applier instrument for failure analysis investigation.The instrument was analyzed and found during robot-assisted low anterior resection (lar) surgery, the single port medium-large clip applier showed awkward movement and clips failed to attach properly; inspection revealed a broken wire, and the procedure was completed using a backup instrument.Failure analysis identified a dislodged instrument cable crimp at the distal joggle joint as the primary cause of the complaint, leading to a broken joggle constraint cable and imprecise motion with yaw friction.No housing damage or missing material was observed.In-house testing confirmed imprecise instrument motion, specifically yaw failure, despite passing recognition and engagement tests.The instrument struggled to straighten during yaw manipulation, likely due to the missing/dislodged crimp.The probable root cause of the customer reported issue of dislodged instrument cable crimp and functional test failure is attributed to the instrument experiencing more load than anticipated.The cable crimp can become dislodged due to back-driving of wrist and joggle joints with the insertion axis.Applying excessive force on the instrument shaft and/or tip during handling, insertion, usage (overloading), or removal can also cause the crimp to dislodge.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MEDIUM-LARGE CLIP APPLIER
• 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: 23698875
• Report Number: 2955842-2025-47161
• Device Sequence Number: 10192484
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(11)221229(10)U10221229
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 430005-57
• Device Catalogue Number: 430005
• Device Lot Number: U10221229 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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