BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22536984 · Received July 17, 2025

    Report

    Report Number
    2955842-2025-30428
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    March 4, 2025
    Report Date
    June 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITH NO DELAYS. NO FRAGMENTS FELL INSIDE THE PATIENT. A DIFFERENT BACKUP INSTRUMENT WAS USED TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. .

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE WHITE SHEATH ON THE BRANCHES TIP BROKE. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING A ROBOTIC DISTAL PANCREATECTOMY ACE ROBOTIC INSTRUMENT REF. 480275 LOT N. L81240702 WHITE SHEATH ON THE BRANCHES TIP BROKE. NO PATIENT ISSUE. C.S. 18234088. BACK-UP INSTRUMENT USED. M75 DV111372.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964718 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-10 L81240702 10886874112738

    Patients

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