BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE RETURN CORD, NON-STERILE, FORCEPS

    MDR report key: 3061163 · Received April 10, 2013

    Report

    Report Number
    2242352-2013-00332
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K870981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BIPOLAR CARD WAS WORKING INTERMITTENTLY. THERE WERE NO VISIBLE ISSUES WITH THE CORD. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149298 ACTIVE RETURN CORD, NON-STERILE, FORCEPS ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC 1838 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA