BEUDAMED
    FDA Adverse Event Other Summary report: N

    YANKAUER SUCTION INSTRUMENT

    MDR report key: 16524 · Received September 30, 1994

    Report

    Report Number
    MW1003548
    Event Type
    Other
    Date Received
    September 30, 1994
    Date of Event
    September 13, 1994
    Report Date
    September 21, 1994
    Manufacturer
    DAVOL, INC.
    Product Code
    JOL
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AT CLOSING OF ABDOMINAL INCISION THE SURGEON NOTICED THAT THE TIP OF THE DISPOSABLE SUCTION TIP WAS VERY SHARP. THE TIP APPEARED TO HAVE BEEN CUT OR SLICED OFF. THERE WAS ABOUT 1 MM OF THE TIP MISSING. NEITHER THE SURGEON OR THE INSTRUMENT TECHS COULD SAY IF THIS HAPPENED DURING THE SURGERY OR IF THE TIP WAS DEFORMED AT THE START OF THE CASE. THE PT'S ABDOMINAL CAVITY WAS INSPECTED FOR FOREIGN OBJECTS; NONE WAS FOUND. OTHER DISPOSABLE TIPS WERE INSPECTED. NO DEFECTS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YANKAUER SUCTION INSTRUMENT SUCTION INSTRUMENT JOL DAVOL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other