BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-COAT MCR HDL KRSN RONG, THIN

    MDR report key: 10703386 · Received October 20, 2020

    Report

    Report Number
    8010386-2020-00001
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    August 27, 2020
    Report Date
    October 20, 2020
    Manufacturer
    S.U.A. MARTIN GMBH & CO. KG
    Product Code
    HAE
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RONGEUR WAS RETURNED WITHOUT THE BROKEN-OFF TIP. MICROSCOPIC INSPECTION OF THE DEVICE REVEALED EVIDENCE OF REPAIR AND/OR REWORK BY UNAUTHORIZED THIRD PARTIES. NOTCHES AND GRINDING MARKS ON THE CUTTING EDGE OF THE RONGEUR AND MARKS ON THE SCREW INDICATE FAULTY REPAIR WORK. POSSIBLY THE MISSING FOOTPLATE WAS ALSO SUBJECT TO GRINDING, DIMINISHING MATERIAL STABILITY AND INCREASING THE RISK OF BREAKAGE. HARDNESS OF THE RETURNED DEVICE WAS TESTED AND FOUND TO CONFORM TO SPECIFICATIONS. REVIEW OF MANUFACTURING DOCUMENTS SHOW THAT THE DEVICE CONFORMED TO SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT BROKE AND WAS RECOVERED DURING THE PROCEDURE WITH NO HARM TO PATIENT. IT WAS NOT NECESSARY TO EXTEND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173935 T-COAT MCR HDL KRSN RONG, THIN KERRISON RONGEUR HAE S.U.A. MARTIN GMBH & CO. KG MS49

    Patients

    Seq Age Sex Outcome Treatment
    1