BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 3061165 · Received April 10, 2013

    Report

    Report Number
    2242352-2013-00327
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICES ARE NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING ROUTINE STERILIZATION, TWO ENDOSCOPES HAD A GLUE-LIKE SUBSTANCE THAT CAME OUT OF THE SCOPE. THE HOSPITAL NOTED THAT THE SUBSTANCE WAS ABLE TO BE SCRAPED OFF OF THE LENS, BUT IT RETURNED AFTER THE SCOPE WAS RE-STERILIZED. THERE WAS NO PATIENT INVOLVEMENT. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153093 7 MM EXTENDED LENGTH ENDOSCOPE ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR, LLC VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA