BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5402249 · Received February 1, 2016

    Report

    Report Number
    2242352-2016-00107
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    January 6, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE WERE OBSERVED. THERE WAS NO BLOOD OBSERVED ON THE DEVICE. THERE WERE NO DEFECTS OBSERVED IN THE VISUAL INSPECTION. AN IMAGE QUALITY INSPECTION WAS PERFORMED WITH AN ENDOSCOPIC VIDEO IMAGING SYSTEM. A CLEAR IMAGE WAS OBTAINED AND THE SIZE OF THE IMAGE WAS DETERMINED TO BE NORMAL. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    FEB. 01, 2016 01:51 PM (GMT-5:00) 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).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE BIO-MED DEPARTMENT RECEIVED A BOM 7MM EXTENDED LENGTH ENDOSCOPE WITH A NOTE STATING THE PICTURE ON THE MONITOR WAS TOO SMALL AND THAT SOMETHING MAY BE WRONG WITH THE SCOPE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE BIO-MED DEPARTMENT RECEIVED A BOM 7MM EXTENDED LENGTH ENDOSCOPE WITH A NOTE STATING THE PICTURE ON THE MONITOR WAS TOO SMALL AND THAT SOMETHING MAY BE WRONG WITH THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61718 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV 523265

    Patients

    Seq Age Sex Outcome Treatment
    1