BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-CABLE, MONOPOLAR, 4 M, UES-30

    MDR report key: 6461900 · Received April 5, 2017

    Report

    Report Number
    2951238-2017-00228
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 16, 2017
    Report Date
    April 5, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    PMA / PMN Number
    PK790071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AS THE DEVICE WAS DISCARDED FOLLOWING THE PROCEDURE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS USER HANDLING/MAINTENANCE. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE CABLE. ¿VISUALLY INSPECT THE CABLE AND THE PLUGS FOR IRREGULARITIES ON THE SURFACE. DO NOT USE A CABLE WITH BRITTLE OR DEFECTIVE INSULATION. REPLACE THE CABLE. IN ORDER TO PLUG OR UNPLUG THE CABLE, ALWAYS PULL AT THE PLUG. NEVER PULL AT THE CABLE OR RISK OF DAMAGING THE CABLE MAY OCCUR.¿ ALSO, ¿WHEN USED AS INTENDED THIS PRODUCT IS MORE OR LESS SUBJECT TO WEAR DEPENDING ON THE INTENSITY OF USE. DO NOT USE THE HF CABLE AFTER ONE YEAR OF USE.¿

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A BLADDER PROCEDURE, THE DEVICE EXPLODED NEAR THE STRAIN RELIEF AT THE CONNECTOR ATTACHED TO THE ELECTROSURGICAL GENERATOR (ESU) AND SPARKS WERE OBSERVED. THE ESU WAS SET TO 20 COAG. NO ERROR MESSAGES WERE OBSERVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN UNSPECIFIED DEVICE. NO PATIENT OR USER INJURIES WERE REPORTED. IN ADDITION, THE USER FACILITY NOTED THAT THE DEVICE WAS APPROXIMATELY 3-4 YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241841 HF-CABLE, MONOPOLAR, 4 M, UES-30 HF-CABLE, MONOPOLAR GCP OLYMPUS WINTER & IBE GMBH A00012A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1