BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18888089 · Received March 12, 2024

    Report

    Report Number
    2955842-2024-12103
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 16, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEGA SUTURE CUT NEEDLE DRIVER WAS RETURNED TO INTUITIVE SURGICAL, INC. FOR FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A FULLY BROKEN GRIP CABLE AT THE PROXIMAL CLEVIS HOLE. 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. AN ADDITIONAL UNRELATED FINDING WAS BLADE DAMAGE AT THE TIP/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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT BROKE INTRA-ABDOMINALLY. ALL PIECES WERE RECOVERED. THE CUSTOMER ADVISED THAT THE INSTRUMENT BROKE WHILE CUTTING SUTURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028442 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K11230713 0042 00886874119815

    Patients

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