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	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Failure analysis found the primary failure of broken input disks to be related to the customer reported complaint.The medium-large clip applier instrument was found to have a broken grip input disk.The input disk controlling the grip of the applier appears completely broken.The breakage was seen reaching all around the input disk.As a result of the fully broken inputs, the instrument failed the clip test but passed the intuitive motion test.Visual inspection was performed and found no damage to the instrument main tube or distal end.The instrument was found to have failed functional testing - clip test.The failed clip test was likely caused by the broken grip input disk.The grips clip test was performed and failed.The clip applier instrument failed the clip test due to misapplication of the clip (the instrument passes engagement and able to retain clip through engagement but cannot apply the clip).Probable root cause of the failure mode broken instrument input disks are attributed to use and incorrect reprocessing conditions.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the medium-large clip applier does not clip.The user completed the procedure with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.

• 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: 24142031
• Report Number: 2955842-2026-01851
• Device Sequence Number: 21165975
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(10)U10230601
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 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: 430005-57
• Device Catalogue Number: 430005
• Device Lot Number: U10230601 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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