BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACURETTE CURRETTE 12MM

    MDR report key: 1275564 · Received December 19, 2008

    Report

    Report Number
    1275564
    Event Type
    Malfunction
    Date Received
    December 19, 2008
    Date of Event
    December 16, 2008
    Report Date
    December 19, 2008
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SUCTION D&C, THE TIP OF THE VACURETTE BROKE DURING THE PROCEDURE. WHEN THE VACURETTE WAS REMOVED FROM THE PATIENT, THE TIP WAS BROKEN BUT STILL ATTACHED. APPROXIMATELY 1MM PIECE WAS BROKEN AT THE TIP BUT STILL ATTACHED. THE SURGICAL TECHNICIAN BROKE THE PIECE OFF WHEN EXAMINING THE PRODUCT. DIFFICULT PROCEDURE WITH ABNORMAL ANATOMY PER DOCTOR. ULTRASOUND TO THE ROOM DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACURETTE CURRETTE 12MM VACURETTE, CURVED HHK GYRUS MEDICAL, INC. * 07083808

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR NONE KNOWN| NONE KNOWN