BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER

    MDR report key: 19645000 · Received June 28, 2024

    Report

    Report Number
    MW5156821
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Report Date
    June 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I AM REPORTING THIS FROM (B)(6), REGARDING SEVERAL DA VINCI XI INSTRUMENTS MADE BY INTUITIVE. SINCE (B)(6) 2024, SIXTEEN DA VINCI XI INSTRUMENTS HAVE BROKEN WHILE INSIDE THE PATIENT, LEAVING A FRAYED WIRE AT THE TIP OF THE INSTRUMENT. THESE INSTRUMENTS ARE: FENESTRATED BIPOLAR FORCEPS: REF#471205, LOT#K13240201, IN THE NUMBER OF 4 INSTRUMENTS; FENESTRATED BIPOLAR FORCEPS: REF#471205, LOT#18240201-0147, IN THE NUMBER OF 2 INSTRUMENTS; FENESTRATED BIPOLAR FORCEPS: REF #471205, LOT#K16240327-0062, IN THE NUMBER OF 1 INSTRUMENT; MONOPOLAR CURVED SCISSORS (HOT SHEARS): REF#470179, LOT #K16240229-0567, IN THE NUMBER OF 2 INSTRUMENTS; MEGA SUTURECUT NEEDLE DRIVER: REF #471309, LOT# K1231130, IN THE NUMBER OF 4 INSTRUMENTS; MEGA SUTURECUT NEEDLE DRIVER: REF#71309, LOT#K11230914, IN THE NUMBER OF 1 INSTRUMENT; CADIERE FORCEPS: REF#471049, LOT# N11200525, IN THE NUMBER OF 1 INSTRUMENT; PROGRASP FORCEPS: REF#471093, LOT#K11220725, IN THE NUMBER OF 1 INSTRUMENT. ALL OF THESE INSTRUMENTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THESE INSTRUMENTS HAVE BROKEN WHILE BEING USED BY SEVERAL DIFFERENT SURGEONS. INTUITIVE HAS COME TO THE FACILITY TO OBSERVE SURGICAL CASES AND THE INSTRUMENT REPROCESSING PROTOCOL, TO WHICH NOTHING SIGNIFICANT WAS FOUND IN OUR PRACTICES THAT WOULD BE CAUSING THE BREAKING OF THESE INSTRUMENTS. REFERENCE REPORTS: MW5156809, MW5156810, MW5156811, MW5156812, MW5156813, MW5156814, MW5156815, MW5156816, MW5156817, MW5156818, MW5156819, MW5156820, MW5156822, MW5156823, MW5156824.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683719 MEGA SUTURECUT NEEDLE DRIVER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. K1231130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown