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

Model Number	430005-62
Medical Device Problem Codes	Material Separation (1562); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer experienced an issue with a medium-large clip applier instrument.A fragment fell into the patient and was retrieved during the same procedure.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during a surgical procedure, the lock of a clip applier broke off completely before the clip was attached, and the missing piece was recovered.The problem was first noticed during the operation and resulted in unsuccessful clip application, specifically incomplete closure of the clip.There was no injury to the patient, but the issue caused a 15-minute delay while a replacement instrument was used to complete the procedure.The clip did detach from the instrument and fall into the patient at the time of the incident, but it was successfully recovered.No unexpected movement occurred either while attempting to place the clip around a vessel/tissue or while closing the clip.
Additional Manufacturer Narrative
The medium-large clip applier instrument has not been received for failure analysis evaluation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The medium-large clip applier instrument has been received for failure analysis evaluation.The instrument was found to have a dislodged grip knob.The grip knob was dislodged from the grip input due to the condition of the grip input groove.For clarification, the grip knob was not returned other the instrument.There were no obvious signs of physical damage on the components adjacent to the grip knob.Each input disk was manually articulated and responded accordingly.There was no damage to the snake wrist, shaft, joggle tube and grip tip.The release buttons were functional.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24545262
• Report Number: 2955842-2026-15407
• Device Sequence Number: 17558279
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(11)250626(10)K10250626
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182371
• 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,Followup
• Report Date (Section B): 04/29/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 430005-62
• Device Catalogue Number: 430005
• Device Lot Number: K10250626 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown