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

Model Number	430005-62
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the single port (sp) medium-large clip applier instrument would not fire the clip.The instrument worked multiple times prior to the incident.The instrument was removed as it was not needed following the non-fire.No fragment fell into the patient.The user completed the procedure and 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.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the single port (sp) medium-large clip applier instrument for failure analysis investigation.The instrument was analyzed and the findings did not replicate or confirm the customer reported event.The reported issue with the instrument was not replicated nor confirmed.The instrument was evaluated and placed on an in-house tester.The qap (quality assurance procedure) was performed and passed.The instrument passed the recognition and engagement tests.Clip test, gripping misalignment, bumper test, and intuitive motion testing was performed and passed.The instrument moved intuitively wit full range of motion in all directions.The grip tips opened and close properly.The instrument was retested and passed all in-house testing all three attempts.A visual inspection of grip tips, cables, and all internal and external components was performed and passed due to no visual damage observed.There was no problem detected.

• Brand Name: ENDOWRIST SP
• 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 ; 4085232100
• MDR Report Key: 23969027
• Report Number: 2955842-2026-00055
• Device Sequence Number: 7946361
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(11)240711(10)K10240711(91)0002
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 430005-62
• Device Catalogue Number: 430005
• Device Lot Number: K10240711 0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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