BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM DISPOSABLE ELECTRODE, L-DIAMOND, 35CM

    MDR report key: 1659671 · Received April 14, 2010

    Report

    Report Number
    1722040-2010-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 9, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    PMA / PMN Number
    K091074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICES WERE NOT RETURNED. SAMPLES FROM THE SAME LOT WERE TESTED IN SIMULATED USE CONDITIONS AND TESTED FOR STATIC AND DYNAMIC LATERAL LOAD. SOME OF THE SAMPLES DID NOT MEET THE STRENGTH SPEC, AND DISPLAYED FAILURE MODES SIMILAR TO THAT DESCRIBED BY THE USER. SAMPLES FROM ADD'L LOTS WERE ALSO TESTED. A PRODUCT RECALL HAS BEEN INITIATED FOR THE AFFECTED LOTS, AND WILL BE REPORTED TO THE FDA DISTRICT OFFICE WITHIN 10 DAYS.

    Description of Event or Problem · 1

    HOSPITAL REPORTED TIP INSULATION OF FOUR DISPOSABLE ELECTRODES CRACKED WHEN BEING CLEANED, AND FELL OFF WHEN TIP WAS BEING CLEANED IN ONE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM DISPOSABLE ELECTRODE, L-DIAMOND, 35CM ELECTROSURGICAL CUTTING AND COAGULATION GEI ENCISION, INC. ES0311 PK

    Patients

    Seq Age Sex Outcome Treatment
    1