BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM 1.0MM 80CM DISPOSABLE ANGIOSCOPE

    MDR report key: 3466447 · Received October 11, 2013

    Report

    Report Number
    2027111-2013-00383
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    August 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    LYK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVAL. UPON INSPECTION, ENGINEERING CONFIRMED THE DEVICE DISPLAYED A SKEWED AND BLURRY IMAGE. NO DAMAGE WAS NOTED TO THE UNIT. ENGINEERING DISASSEMBLED THE UNIT AND FOUND THAT ONE EYEPIECE LENS WAS OUT OF ITS PROPER POSITION. ALL ENDOSCOPES UNDERGO 100% VISUAL INSPECTION AND ARE FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS. IT IS LIKELY THAT THE LENS WAS NOT SECURED IN ITS PROPER POSITION DUE TO AN OPERATOR ERROR AND BECAME DETACHED INSIDE THE EYEPIECE DURING SHIPPING AND HANDLING OF THE PRODUCT. THE PRODUCTION TEAM HAS BEEN NOTIFIED OF THIS OCCURRENCE IN ORDER TO DEVELOP A HEIGHTENED AWARENESS OF THE INCIDENT. THIS DOCUMENT REPRESENTS OUR INITIAL/FINAL REPORT.

    Description of Event or Problem · 1

    LEFT FEM-POP BYPASS WITH INSERTION OF SAPHENOUS VEIN: "DISPOSABLE ANGIOSCOPE WOULD NOT DISPLAY PICTURE DURING SURGICAL PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521829 2.3MM 1.0MM 80CM DISPOSABLE ANGIOSCOPE NONE LYK APPLIED MEDICAL ANG-080-D10K 1174936

    Patients

    Seq Age Sex Outcome Treatment
    1