BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19663067 · Received July 3, 2024

    Report

    Report Number
    2955842-2024-16606
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 23-JUL-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5156821 STATING: 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, MW5156821, MW5156822, MW5156823, MW5156824. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE IDLER PULLEYS. THE CABLE WAS FULLY BROKEN. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPONENTS SURROUNDING THE BROKEN CABLE DID NOT EXHIBIT ABNORMAL SHARP EDGES OR DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE CABLE ON A MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT SNAP WHILE SUTURING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684417 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K12231130 0421 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.