BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID CURVE POSITIONER

    MDR report key: 417914 · Received September 4, 2002

    Report

    Report Number
    2532140-2002-00007
    Event Type
    Malfunction
    Date Received
    September 4, 2002
    Date of Event
    February 12, 2002
    Report Date
    September 4, 2002
    Manufacturer
    POWER MEDICAL INTERVENTIONS
    Product Code
    EXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DIFFICULTY INSERTING 29MM DLU INTO RECTUM; THREE DLUS DETACHED FROM "FLEXSHFT" AT THE RECTAL STUMP. REQUIRED MUCH WORK TO ACCESS AND RETRIEVE DETACHED DLUS TRANSANALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGID CURVE POSITIONER PROBE DIRECTOR EXX POWER MEDICAL INTERVENTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R