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

Model Number	470230-12
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, a large hem-o-lok clip applier instrument would not clamp clip.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the large hem-o-lok clip applier instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the reported complaint.The instrument was found to have grip input disk broken.Input disk 6 was found completely detached from the base of the housing.The instrument was found to have hairline cracks on grip input disk #7.The probable root cause is attributed to use and reprocessing conditions.The input disk can be susceptible to chemical or thermal stresses, which can result in the appearance of cracks in the ultem or peek material.Under repeated or prolonged chemical or thermal exposure cycles, these cracks can propagate into larger cracks, and may cause the input disk to break and separate from the instrument.

• 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: 50910835
• Report Number: 2955842-2026-40138
• Device Sequence Number: 5777949
• Product Code: NAY
• UDI-Device Identifier: 00886874112380
• UDI-Public: (01)00886874112380(11)210304(10)N10210308
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 470230-12
• Device Catalogue Number: 470230
• Device Lot Number: N10210308 0169
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/19/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Patient Sex: Unknown