BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNIFYING LPE 2.5X RED R 12IN TO 15IN WRKG DIST

    MDR report key: 14751103 · Received June 21, 2022

    Report

    Report Number
    3014334038-2022-00124
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Report Date
    June 21, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HJH
    UDI-DI
    10381780462453
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MAGNIFYING LOUPE, 2.5X RED FRAME, 12IN TO 15IN WORKING DISTANCE (1-5001) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD: NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. FAILURE ANALYSIS: EVALUATION OF THE RETURNED MAGNIFYING LOUPE FOUND THE DEVICE WAS IN USED CONDITION WITH THE ADJUSTMENT KNOBS DISCONNECTED. ROOT CAUSE ANALYSIS: THE COMPLAINT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE RETURNED MAGNIFYING LOUPE HAD ITS ADJUSTMENT KNOB BROKEN OFF DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UP AND DOWN MECHANISM OF THE MAGNIFYING LOUPE (1-5001) WAS NOT WORKING. NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043797 MAGNIFYING LPE 2.5X RED R 12IN TO 15IN WRKG DIST M5 - GENERAL SURGERY HJH INTEGRA LIFESCIENCES MANSFIELD 1-5001 W2102005 10381780462453

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown