BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIS NON STICK MIRROR FINISH 6, .4MM TIP

    MDR report key: 6392727 · Received March 9, 2017

    Report

    Report Number
    1226348-2017-10150
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    January 30, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    K963499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE EVALUATION PERFORMED BY R&D REVEALED THAT THE TIPS ARE EXCESSIVELY DISCOLORED/CHARRED. THE CONDITION OF THE TIPS IS ASSOCIATED WITH EXCESSIVE HEAT SETTING RESULTING IN CHARRING/BURNING. THE EXACT ROOT CAUSE OF THE REPORTED "SMOKE WAS GENERATED FROM GAUZES WHEN USING THE REPORTED DEVICE" COULD NOT BE VERIFIED; HOWEVER, THIS INSTRUMENT IS NON INSULATED; THEREFORE IT IS NOT RECOMMENDED FOR CONTACT WITH WET TISSUE. IT IS LIKELY THAT THIS INSTRUMENT WAS USED FOR THE WRONG APPLICATION AND EXCESSIVE HEAT WAS INTRODUCED RESULTING IN SMOKING AND CHARRED TIPS, THIS HOWEVER COULD NOT BE CONFIRMED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMOKE WAS GENERATED FROM GAUZES WHEN USING THE REPORTED DEVICE (80-2940) DURING A SURGERY ON (B)(6) 2017. THE REPORTED DEVICE WAS USED WITH AESCULAP¿S GENERATOR AND CABLE. THE LOCATION WHERE THE SMOKE GENERATED WAS NOT IDENTIFIED. THE SURGEON STOPPED USING THE PRODUCT AFTER NOTICING THE SMOKE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175512 MALIS NON STICK MIRROR FINISH 6, .4MM TIP ELECTROSUGICAL, CUTTING & COAG ACCES. GEI CODMAN & SHURTLEFF, INC. 1411

    Patients

    Seq Age Sex Outcome Treatment
    1