BEUDAMED
    FDA Adverse Event Other Summary report: N

    RHOTON TRARDROP DISSECTOR

    MDR report key: 709703 · Received May 5, 2006

    Report

    Report Number
    1226348-2006-00098
    Event Type
    Other
    Date Received
    May 5, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HAO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "INSTRUMENT BROKE AT THE TIP. NO DELAY IN SURGERY OR RISK TO THE PATIENT. IT IS UNCLEAR IF THE INSTRUMENT WAS BROKEN BEFORE USE A C-ARM WAS USED AND THE TIP HAS NOT BEEN FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHOTON TRARDROP DISSECTOR INSTRUMENTS MICRO SURGICAL HAO CODMAN & SHURTLEFF, INC. NA 0602N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other