BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAPETTE

    MDR report key: 900476 · Received July 6, 2007

    Report

    Report Number
    900476
    Event Type
    Malfunction
    Date Received
    July 6, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 6, 2007
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Product Code
    HHT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MD WAS PERFORMING A PAP SMEAR WITH A PAPETTE BRUSH. AS HE WAS REMOVING THE DEVICE, THE WHITE BRUSH TIP CAME OFF OF THE HANDLE AND FELL INTO THE VAGINAL CANAL. THE RN WENT TO THE ED TO OBTAIN A PAIR OF FORCEPS SO THAT THE MD COULD REMOVE THE BRUSH. THE PATIENT WAS NOT INJURED. THE MD IS EXPERIENCED IN USING THIS DEVICE & HAS NOT HAD THIS HAPPEN BEFORE. THE BRUSH WAS NOT FORCED INTO THE CERVICAL OS AND THE MD HAD NO DIFFICULTY USING THE DEVICE. THE MD DISCARDED THE DEVICE; HOWEVER, THE BAG FROM WHICH THIS DEVICE CAME WAS CHECKED. OF THE SIX PAPETTES REMAINING, ONE HAS A BRUSH THAT IS VERY LOOSE AND EASILY COMES OFF. THE OTHER FIVE PAPETTE BRUSHES ARE SECURELY FASTENED TO THE HANDLES. THE MD WAS ABLE TO REMOVE THE BRUSH FROM THE VAGINAL CANAL AND CONTINUE WITH THE EXAM. THE MD AND STAFF IDENTIFIED THAT THE PATIENT WAS OBESE, BUT BELIEVE THAT THIS WAS NOT A FACTOR IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAPETTE CELL COLLECTOR, CERVICAL HHT WALLACH SURGICAL DEVICES, INC. * 12X1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR