BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSHING NON STICK MIRROR FINISH , 7, 1.65MM TIP

    MDR report key: 3812454 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-11631
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GEI
    PMA / PMN Number
    PK963499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE ELECTROSURGICAL FORCEPS WERE ANALYZED. DOUBLED GLOVES WERE USED AND A SALINE TEST WAS PERFORMED IN COAGULATION AND CUT MODES AT 30 WATTS. TWO SAMPLES DEMONSTRATED NO ISSUES WITH RESPECT TO THE GENERATED HEAT THAT COULD BE SENSED BY THE OPERATOR. BOTH PRODUCT ARE FUNCTIONING NORMALLY. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED "THE HOSPITAL WOULD LIKE TO REPAIR 80-2925 WHICH GENERATES TOO MUCH HEAT ON THE HANDLE. A SURGEON SAID THAT HE CAN FEEL THE ELECTRICITY ON THE TIP HANDLE COMPARED TO HIS PREVIOUS 80-2925. PLEASE EVALUATE IT". INCIDENT OCCURED BEFORE USE ON PATIENT. THE INSTRUMENTS (2) WERE FORWARDED TO (B)(4) FOR FUNCTIONAL TESTING ON (B)(4) 2012. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291675 CUSHING NON STICK MIRROR FINISH , 7, 1.65MM TIP ELECTROSURGICAL, CUTTING AND COAGULATION ACCESS GEI CODMAN & SHURTLEFF 1003N

    Patients

    Seq Age Sex Outcome Treatment
    1