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	Insufficient Information (4580)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection (lar) surgical procedure, the clip did not come off the 8mm large hem-o-lok clip applier instrument.No fragment fell into the patient.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.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.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• 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: 50877581
• Report Number: 2955842-2026-39841
• Device Sequence Number: 9224299
• Product Code: NAY
• UDI-Device Identifier: 00886874112380
• UDI-Public: (01)00886874112380(11)231005(10)K11231005
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: K11231005 0218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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