BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5534916 · Received March 30, 2016

    Report

    Report Number
    2242352-2016-00299
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Report Date
    March 2, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAR. 29, 2016 10:07 AM (GMT-4:00) ADDED BY (B)(6): 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW WAS NOT APPLICABLE. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    MAR. 04, 2016 02:53 PM (GMT-5:00) ADDED BY (B)(6): THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THEY NOTICED BOM 7MM EXTENDED LENGTH ENDOSCOPE WAS CLOUDY. THE SCOPE WAS PURCHASED ON PO (B)(4) 08/31/2015. MAR. 02, 2016 06:00 PM (GMT-5:00) ADDED BY (B)(6): NOTICED IT WAS CLOUDY WHILE GETTING READY - I HAVE SENT REPLACEMENT OVERNIGHT (ORIGINALLY PURCHASED UNDER PO# (B)(4) 8/31/2015).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THEY NOTICED BOM 7MM EXTENDED LENGTH ENDOSCOPE WAS CLOUDY. THE SCOPE WAS PURCHASED ON (B)(6) 2015. NOTICED IT WAS CLOUDY WHILE GETTING READY - I HAVE SENT REPLACEMENT OVERNIGHT (ORIGINALLY PURCHASED UNDER PO (B)(6) 2015).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192000 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1