MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; LARGE HEM-O-LOK CLIP APPLIER

Model Number	470230-15
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a medium large clip applier instrument had an exposed wire.The arm was broken and nonfunctional.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The medium large clip applier instrument was analyzed and found the instrument was tested on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grip tips opened and closed properly.The clip was unable to be loaded on the grips successfully.The instrument failed the clip test.The instrument was found to have bent grips.No other product issue was found.The instrument was found to have one (1) severely bent grip, causing misalignment of the grip-tips.There was a.73mm offset at the tips.A clip was able to be loaded into the clip groove of the grip-tips.The clip applier failed the clip tests.Instrument was installed on an in-house system and driven.The clip applier instrument failed the clip test due to the grip tips being severe.The clip was unable to be installed on the grips properly, causing clip test failure.The complaint regarding the instrument had an exposed wire and a broken arm was not confirmed by failure analysis.The probable root cause can be attributed to damage during either use or reprocessing causing improper grip alignment, preventing proper clip formation.

• Brand Name: EndoWrist
• Common Device Name: LARGE HEM-O-LOK 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 ; +1(408)523-2100
• MDR Report Key: 50797845
• Report Number: 2955842-2026-39122
• Device Sequence Number: 13154218
• Product Code: NAY
• UDI-Device Identifier: 00886874112380
• UDI-Public: (01)00886874112380(10)K10251218
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• 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
• Report Date (Section B): 09/22/2026

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: 470230-15
• Device Catalogue Number: 470230
• Device Lot Number: K10251218 0077
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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