BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-CABLE, MONOPOLAR, 3.5 M, UES-30,

    MDR report key: 5748259 · Received June 24, 2016

    Report

    Report Number
    2951238-2016-00533
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 24, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    DSA
    PMA / PMN Number
    PK944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, THE INSTRUCTION MANUAL CONTAINS WARNING STATEMENTS IN AN EFFORT TO PREVENT SPARKING AND PATIENT INJURY. "BEFORE USE, MAKE SURE THAT THE PRODUCT HAS BEEN PROPERLY REPROCESSED, INSPECTED, AND TESTED. IMPROPER USE OF HF CURRENT CAN CAUSE ENDOGENOUS OR EXOGENOUS BURNS, AND EXPLOSIONS. RISK OF DEATH OR SERIOUS INJURY MAY OCCUR."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AT THE START OF AN UNSPECIFIED PROCEDURE, THE HIGH FREQUENCY (HF) CABLE SPARKED ON THE GENERATOR CONNECTING END. THERE WAS NO PATIENT OR USER INJURY REPORTED. NO FIRE EMERGENCY EVACUATION TOOK PLACE. THE GENERATOR WAS A NON OLYMPUS DEVICE (VALLEY LAB). THE CABLE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401696 HF-CABLE, MONOPOLAR, 3.5 M, UES-30, HF CABLE DSA OLYMPUS WINTER & IBE GMBH A0358 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1