BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669E DIA 5MM ERG BIPOLAR [MXI/XOM]

    MDR report key: 3485588 · Received November 25, 2013

    Report

    Report Number
    9680837-2013-00498
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 31, 2013
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: CEV649B5, TUBE DIAM 5MM 310MM, LOT #130401, MFG DATE APRIL 2013, K993655; CEV625H, BIPOLAR INSERT DIM 5MM FENESTRAT, LOT #130601, MFG DATE JUNE 2013, K993655. (B)(4). PRODUCT ANALYSIS FOUND THE ELECTRICAL TESTS PERFORMED ON THIS HANDLE FAILED. THE HANDLE IS ON SHORT CIRCUIT. AFTER DISSEMBLING, IT WAS NOTED A TRACE OF PLASTIC BURNT AT THE SCREW HOLE LEVEL. FOR THE TWO CONCOMITANT DEVICES, THERE WERE NO ISSUES HIGHLIGHTED. INSTRUMENTS WERE CONFORMING TO MANUFACTURING SPECIFICATIONS. ELECTRICAL TESTS DID NOT SHOW AN ELECTRICAL INSULATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICES WERE RETURNED FOR NOT WORKING. INVESTIGATION FOUND THE ELECTRICAL TESTS PERFORMED ON THIS HANDLE FAILED. THE HANDLE IS ON SHORT CIRCUIT. AFTER DISSEMBLING, IT WAS NOTED A TRACE OF PLASTIC BURNT AT THE SCREW HOLE LEVEL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613126 HANDLE CEV669E DIA 5MM ERG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669E 101101

    Patients

    Seq Age Sex Outcome Treatment
    1