BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 23984755 · Received January 6, 2026

    Report

    Report Number
    2955842-2026-00108
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 15, 2025
    Report Date
    April 2, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114285
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND THE RETAINING COVER AND METAL ACCESSORY WERE RETURNED DETACHED. ALTHOUGH THE ACCESSORY WAS DETACHED, VISUAL INSPECTION FOUND NO DAMAGE. THE RETAINING COVER AND METAL ACCESSORY WERE REINSTALLED. THE ACCESSORY WAS SUCCESSFULLY INSTALLED ON AN IN-HOUSE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE INSTRUMENT WAS PLACED ON THE IN-HOUSE SYSTEM FOR TESTING. THERE WAS NO TIP DETECTION FAILURE REGARDING THE MCS ACCESSORY OBSERVED. THE INSTRUMENT ALSO TESTED FOR ENERGY DELIVERY WITH THE RETURNED MCS TIP ACCESSORY AND PASSED. NO PRODUCT ISSUE WAS IDENTIFIED. THE COMPLAINT REGARDING THE PLASTIC PART AND SCISSORS WERE DISCONNECTED WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 INSTRUMENT UPDATED BASED OFF OF INFORMATION OBTAINED FROM CUSTOMER. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER STATED THAT THEY ARE UNSURE WHAT CAUSED THE DAMAGE, IT WAS DISCONNECTED WHEN THE PACK WAS OPENED. THERE WAS NO DAMAGE AT THE DISTAL END OF THE INSTRUMENT AND THE SPECIFIC INSTRUMENT INFORMATION IS 430004-62 LOT: K10250320-0029 AND THE INSTRUMENT WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 0

    THE SINGLE-PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START (POST-ANESTHESIA) OF A DA VINCI-ASSISTED GYNECOLOGY SURGICAL PROCEDURE, THE SINGLE-PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP AND THE SP MCS INSTRUMENT WERE DISCONNECTED. THE SP MCS TIP WAS NOT USED ON THE PATIENT. NO FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348334 NONE MONOPOLAR CURVED SCISSORS (MCS) TIP NAY INTUITIVE SURGICAL, INC 430004-62 K10250320 0029 00886874114285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES