BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEGIANCE POOLE SUCTION INSTRUMENT

    MDR report key: 423752 · Received October 18, 2002

    Report

    Report Number
    2433012-2002-00001
    Event Type
    Other
    Date Received
    October 18, 2002
    Date of Event
    September 1, 2002
    Report Date
    October 17, 2002
    Manufacturer
    BUSSE HOSPITAL DISPOSBLES
    Product Code
    EBR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PHONED DISTRIBUTOR AND STATED THAT HE WAS USING THE POOLE SUCTION HANDLE DURING AN ORTHOPEDIC SURGERY AND HE USED THE HANDLE TO PUSH ON A STRUCTURE IN THE SHOULDER AND THE HANDLE BROKE. A PIECE BROKE OFF. PHYSICIAN NOT CERTAIN WHERE THE PIECE IS. CT SCAN WAS DONE AND THE PIECE COULD NOT BE FOUND. PHYSICIAN ADMITTED TO USER ERROR. HE JUST WANTED TO KNOW IF IT WAS IN THE PATIENT COULD HE LEAVE IT WITH NO PATIENT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE POOLE SUCTION INSTRUMENT POOLE SUCTION INSTRUMENT EBR BUSSE HOSPITAL DISPOSBLES * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other