BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC EXTENSION CABLE

    MDR report key: 3880859 · Received April 9, 2014

    Report

    Report Number
    2242352-2014-00428
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THEY HAD A DC EXTENSION CABLE THAT DID NOT WORK. THE DEFECT WAS NOTICED DURING THE PRE-CAUTERY TEST. THE DEVICE WILL NOT BE RETURNED, AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213389 DC EXTENSION CABLE ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3030 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI