BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20660875 · Received November 12, 2024

    Report

    Report Number
    2955842-2024-21832
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    September 4, 2024
    Report Date
    October 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112441
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM SMALL GRASPING RETRACTOR INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A BROKEN DISTAL PITCH CABLE AT THE CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE CABLE WAS FULLY BROKEN. THERE WAS NO DISCOLORATION, CORROSION, OR CONTAMINATION ON THE CABLE TO SUGGEST IMPROPER REPROCESSING AS A CONTRIBUTING FACTOR. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM SMALL GRASPING RETRACTOR INSTRUMENT WIRE HAD BECOME LOOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE A FOLLOW-UP ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS COULD BE PROVIDED AND OBTAINED THE FOLLOWING: THE CUSTOMER REPORTED THAT THEY DID NOT HAVE ANY FURTHER INFORMATION TO SHARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530140 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 N10190930 0036 00886874112441

    Patients

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