BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 6366827 · Received February 28, 2017

    Report

    Report Number
    2242352-2017-00197
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 30, 2017
    Report Date
    February 28, 2017
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE FIBERS BURNED SO THERE IS LOW LIGHT OUTPUT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE FIBERS BURNED SO THERE IS LOW LIGHT OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146164 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1