BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18708762 · Received February 15, 2024

    Report

    Report Number
    2955842-2024-11453
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 21, 2024
    Report Date
    January 24, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA)) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE 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. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE AT THE MIDPOINT OF THE BLADE. BOTH BLADE EDGES WERE INDENTED. THE CUTTING EDGE DID NOT EXHIBIT ANY SIGNS OF CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, THE LARGE SUTURE CUT NEEDLE DRIVER WAS FOUND TO HAVE BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159048 ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471296-07 T10200729 0015

    Patients

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