BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5528717 · Received March 28, 2016

    Report

    Report Number
    2242352-2016-00290
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Report Date
    February 29, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW IS NOT APPLICABLE. BASED ON THE SERIAL NUMBER PROVIDED AND A REVIEW OF THE SALES HISTORY TO THE ACCOUNT, THE DEVICE WAS SOLD TO THE ACCOUNT PRIOR TO 2009. 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 BOM 7MM EXTENDED LENGTH ENDOSCOPE WAS CAPTURING STRANGE IMAGES. POSSIBLY, HAD BEEN DROPPED. ONLINE IFU INSTRUCTIONS WERE GIVEN OVER THE PHONE. THE SCOPE SERIAL NUMBER IS (B)(4) AND THE WARRANTY HAS EXPIRED. THE CUSTOMER CALLED SEEKING OUR ONLINE IFU FOR THE VH-1111, SPECIFICALLY RESEARCHING CLEANING METHODS. I WALKED HER THROUGH OUR WEBSITE. WHILE WE WERE ON THE PHONE TOGETHER, SHE TOLD ME WHAT WAS GOING ON. THEIR SCOPE [S/N (B)(4) LONG OUT OF WARRANTY] WAS CAPTURING STRANGE IMAGES. SHE SAID IT MAY HAVE BEEN DROPPED.

    Description of Event or Problem · 1

    (B)(4). THE HOSPITAL REPORTED THAT BOM 7MM EXTENDED LENGTH ENDOSCOPE WAS CAPTURING STRANGE IMAGES. POSSIBLY, HAD BEEN DROPPED. ONLINE IFU INSTRUCTIONS WERE GIVEN OVER THE PHONE. THE SCOPE SERIAL NUMBER IS (B)(4) AND THE WARRANTY HAS EXPIRED. (B)(4). THE CUSTOMER CALLED SEEKING OUR ONLINE IFU FOR THE VH-1111, SPECIFICALLY RESEARCHING CLEANING METHODS. I WALKED HER THROUGH OUR WEBSITE. WHILE WE WERE ON THE PHONE TOGETHER, SHE TOLD ME WHAT WAS GOING ON. THEIR SCOPE [S/N (B)(4) LONG OUT OF WARRANTY] WAS CAPTURING STRANGE IMAGES. SHE SAID IT MAY HAVE BEEN DROPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184335 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1