BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 3880842 · Received April 9, 2014

    Report

    Report Number
    2242352-2014-00416
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BOM 7MM EXTENDED LENGTH ENDOSCOPE WAS FOGGY AND CLOUDY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214079 BOM 7MM EXTENDED LENGTH ENDOSCOPE ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR, LLC VA-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI