BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5452102 · Received February 22, 2016

    Report

    Report Number
    2242352-2016-00162
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Report Date
    January 27, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW IS NOT APPLICABLE . THE CUSTOMER REPORTED THAT THE WARRANTY EXPIRED ON JANUARY 24, 2012. A REVIEW OF THE CERTIFICATE OF CONFORMITY (C OF C) IS NOT APPLICABLE BECAUSE THIS EVENT OCCURRED WELL PAST THE SPECIFIED DEVICE LIFETIME RELIABILITY UNDER A 1-YEAR WARRANTY; 48 USES AT AVERAGE VOLUME AND 105 USES AT HIGH VOLUME.

    Additional Manufacturer Narrative · 1

    (B)(4):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.(B)(4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE SCOPE STOPPED WORKING. THEY CALLED AND ASKED FOR SCOPE REPAIRS AND WERE GIVEN THE CONTACT INFORMATION FOR SCHOELLY IMAGING. THE WARRANTY EXPIRED JANUARY 24, 2012. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE SCOPE STOPPED WORKING. THEY CALLED AND ASKED FOR SCOPE REPAIRS AND WERE GIVEN THE CONTACT INFORMATION FOR SCHOELLY IMAGING. THE WARRANTY EXPIRED JANUARY 24, 2012. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109735 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1