BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE 10 FEET

    MDR report key: 1737918 · Received June 11, 2010

    Report

    Report Number
    2430952-2010-00025
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Report Date
    June 11, 2010
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS
    Product Code
    HFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED FOR THIS PRODUCT ONLY BECAUSE AN MDR WAS FOUND ON TWO YEAR LOOK BACK. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTS THAT THERE IS A POSSIBLE ELECTRICAL LEAKAGE. ELECTRODE IS NOT CAUTERIZING. NO PATIENT INJURY. ON (B)(6) 2010, THE CLINICAL MANAGER OF THE OPERATING ROOM REPORTS VIA TELEPHONE THAT THERE WAS NO PATIENT INCIDENT/EVENT EXCEPT THAT THERE WAS APPARENTLY NO CURRENT GOING TO THE ELECTRODE BEING USED WITH THIS MONOPOLAR CABLE, THE DEVICE DID NOT ACTIVATE. SHE CONFIRMED NO PATIENT HARM, DEVICE DID NOT WORK. THIS MDR IS BEING FILED ONLY BECAUSE AN MDR WAS FOUND ON A 2 YEAR LOOK BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CABLE 10 FEET ELECTROSURGICAL COAGULATION HFG J. JAMNER SURGICAL INSTRUMENTS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 PRODUCT # 600-318 L-SHAPED HOOK ELECTRODE 5MM 32CM