BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1X FISCHER CONE BIOPSY WITH EXCISOR - SIZE SMALL

    MDR report key: 1657870 · Received April 7, 2010

    Report

    Report Number
    MW5015507
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    March 19, 2010
    Report Date
    April 7, 2010
    Manufacturer
    APPLE MEDICAL CORP.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER: APPLE MEDICAL CORP. PRODUCT: 1X FISCHER CONE BIOPSY EXCISOR, SIZE: SMALL, REF: 900-156, LOT#: 1299L, EXP 9/12, MFG 09/09, CAUTERY SET TO 40/40 ACCORDING TO MFR RECOMMENDATIONS. WHEN THE SURGEON STARTED USING THE PRODUCT, IT MELTED LEAVING A HOLE IN THE PRODUCT AND A SMALL PIECE OF THE PRODUCT INSIDE THE PT. THE PIECE OF PLASTIC THAT REMAINED IN THE PT WAS REMOVED. THE NEW CAUTERY TIP WORKED WITHOUT ANY PROBLEMS AND THE CASE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. EVENT ABATED AFTER USE: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1X FISCHER CONE BIOPSY WITH EXCISOR - SIZE SMALL NONE KNW APPLE MEDICAL CORP. 1299L

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR