BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1060054 · Received June 4, 2008

    Report

    Report Number
    3004659744-2008-00006
    Event Type
    Injury
    Date Received
    June 4, 2008
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    k042438
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE LG CABLE WAS RETURNED FROM THE SITE AND EVALUATED. THE EVAL DETERMINED THAT THERE ARE BROKEN WIRES AT THE CONNECTOR END OF THE CABLE RENDERING THE DEVICE INOPERABLE. THE INSPECTION OF THE CABLE SHOWED THAT THERE IS DAMAGE AT THE CONNECTOR END OF THE CABLE WHICH MAY HAVE BEEN CAUSED BY EXCESSIVE PULLING OR IMPROPER DISCONNECTION FROM THE UNION. THE SYS USER MANUAL CONTAINS A WARNING "TO AVOID ELECTRICAL SHOCK AND OR SYS FAILURE, DO NOT PINCH, CRIMP, OR OTHERWISE STRESS CABLES AND CONNECTORS". THE PROCEDURE IS TYPICALLY PERFORMED UNDER LOCAL ANESTHESIA. HOWEVER, THIS EVENT COMBINES A MALFUNCTION THAT RENDERED THE SYS UNAVAILABLE WITH A PT WHO WAS UNDER GENERAL ANESTHESIA. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED DUE TO THE ADD'L POTENTIAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * JAK SUPERDIMENSION, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *