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

Model Number	470327-12
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip of a medium-large clip applier instrument would not hold clip.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the medium-large clip applier instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found with one grip bent.The damage was found near the top of the clip groove, causing an offset at the tips.As a result, a clip cannot be properly loaded into the clip groove of the grip-tips.Components adjacent to this severely bent grip do not show damage.Additional observation related to customer complaint: the instrument was unable to be tested for clip test.The instrument was found to have grips prong bent and the tip does not align with the other grip.As a result, a clip cannot be properly loaded into the clip groove of the grip-tips.The probable root cause of bent grip prong is attributed to damage during either use or reprocessing, as severe misalignment of grip tips can be due to accidental drops, incorrect instrument tray or sink sizes for reprocessing, or overloading the tips by applying excessive force on the jaws.The probable root cause for unable to perform clip test is due to bent grip prongs.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• Brand Name: EndoWrist
• 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 ; +1(408)523-2100
• MDR Report Key: 50910831
• Report Number: 2955842-2026-40132
• Device Sequence Number: 14897453
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(11)230928(10)K11230928(91)0006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/27/2026

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: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: K11230928 0140
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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