BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EURO-MED

    MDR report key: 1023466 · Received April 2, 2008

    Report

    Report Number
    1216677-2008-00008
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE SUBJECT HAS NOT BEEN RECEIVED. A UPS CALL TAG HAS BEEN ISSUED WITH THE DEVICE PICKED UP BY THE CARRIER, HOWEVER, THE DEVICE HAS NOT BEEN DELIVERED. THE REPORT WILL BE APPROPRIATELY SUPPLEMENTED UPON ARRIVAL.

    Description of Event or Problem · 1

    DURING A CERVICAL BIOPSY, THE BIOPSY TIP BROKE INSIDE THE PT. THE PIECE REMAINED IN THE PT FOR APPROX A WEEK. THE PIECE WAS REMOVED DURING A LEEP EXCISION. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO-MED ROTATING BIOPSY TIP KNW COOPERSURGICAL, INC. 64-651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention