BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22014638 · Received May 13, 2025

    Report

    Report Number
    2955842-2025-20290
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 23, 2025
    Report Date
    April 23, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE (1) SEVERELY BENT GRIP, CAUSING THEM TO BE MISALIGNED. THE GRIPS WERE NOT FOUND TO BE CRACKED. A CLIP CANNOT BE PROPERLY LOADED INTO THE CLIP GROOVE OF THE GRIP-TIPS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF SEVERELY BENT GRIPS IS ATTRIBUTED TO DAMAGE EITHER DURING USE OR REPROCESSING, AS SEVERE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO ACCIDENTAL DROPS, INCORRECT INSTRUMENT TRAY OR SINK SIZES FOR REPROCESSING, OR OVERLOADING THE TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE MEDIUM-LARGE CLIP APPLIER WOULD NOT CLOSE ALL THE WAY AND NOT ALLOW THE SURGEON TO CLIP THE ARTERY OR DUCT. CUSTOMER TRIED RELOADING IT SEVERAL TIMES AND EVENTUALLY REPLACED IT AND THE NEXT ONE WORKED GREAT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INCIDENT OCCURRED WHILE THE SURGEON ATTEMPTED TO CLOSE THE CLIP ON A VESSEL OR TISSUE BUNDLE. THE ISSUE LED TO AN UNSUCCESSFUL CLIP APPLICATION. A BACKUP CLIP APPLIER WAS USED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880078 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K12240411 0053 00886874112465

    Patients

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