BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIS NON STICK MIRROR FINISH 6, .4MM TIP

    MDR report key: 6117786 · Received November 21, 2016

    Report

    Report Number
    1226348-2016-10793
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 28, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    K963499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE EVALUATION OF THE INSTRUMENT REVEALED THAT THE TIPS ARE EXCESSIVELY DAMAGED. THE TIPS ARE DISCOLORED AND MELTED. THIS DAMAGE IS CONSISTENT WITH EXCESSIVE HEAT INTRODUCED TO THE INSTRUMENT RESULTING IN MELTING OF THE METAL TIPS. IT IS LIKELY THAT THE HEAT SETTING WAS TOO HIGH AND RESULTED IN THE DAMAGE FOUND ON THE TIPS, THIS HOWEVER COULD NOT BE CONFIRMED. IT IS RECOMMENDED THAT THE INSTRUCTIONS FOR USE BE FOLLOWED TO INSURE PROPER INSTRUMENT FUNCTION AND PREVENT INSTRUMENT DAMAGE. THERE ARE NO OTHER ANOMALIES NOTED ON THIS INSTRUMENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE SURGERY WAS PERFORMED FOR STA ANEURYSM TO THE PATIENT, DURING PEELING OFF THE BLOOD VESSEL. THE DEVICE WAS USED WITH 80-2940. THE SPARK OCCURRED DURING SURGERY. THE TIPS WERE MELTED AND BECAME MASS. THE TISSUE WAS NO BURN SO THE EVENT HAPPENED AFTER WIPE OFF THE TIP. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767845 MALIS NON STICK MIRROR FINISH 6, .4MM TIP ELECTROSUGICAL, CUTTING & COAG ACCES. GEI CODMAN & SHURTLEFF, INC. 1104N

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR