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

Model Number	470230-12
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced an issue with a large hem o lok clip applier instrument.There was no report of patient involvement or patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The large hem o lok clip applier instrument was analyzed and found to have grip input disk axis 7 broken into pieces inside the housing.As a result of the fully broken inputs, functional testing for motion related issues could not be performed.Additionally, the instrument was found to have grip input disk axis 6 broken into pieces inside the housing.As a result of the fully broken inputs, functional testing was performed and clip test failed.The complaint regarding an issue experienced with the instrument was confirmed by failure analysis.The probable root cause is attributed to use and reprocessing conditions.

• 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: 50864102
• Report Number: 2955842-2026-39710
• Device Sequence Number: 13430360
• Product Code: NAY
• UDI-Device Identifier: 00886874112380
• UDI-Public: (01)00886874112380(11)210624(10)N10210628
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/22/2026

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: 470230-12
• Device Catalogue Number: 470230
• Device Lot Number: N10210628 0222
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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: ISIFA2022-05-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Patient Sex: Unknown