BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTACT BREAST LESION EXCISION SYSTEM

    MDR report key: 1222109 · Received November 5, 2008

    Report

    Report Number
    1226766-2008-00006
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 6, 2008
    Manufacturer
    INTACT MEDICAL
    Product Code
    KNW
    PMA / PMN Number
    K060413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GJ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTACT MEDICAL WAS NOTIFIED BY ITS DISTRIBUTOR ON SEPT 29, 2008 OF TWO ALLEGED WAND FAILURES- ONE "EMPTY BASKET" AND ONE "WAND STUCK OPEN". NEITHER OF WHICH INDICATED THE NEED FOR FILING A MEDWATCH REPORT. ADDITIONAL INFO WAS RECEIVED FROM THE THIRD PARTY DISTRIBUTOR ON OCT 6, 2008 INDICATED THAT SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE "STUCK" WAND. NO FURTHER INFO HAS BEEN MADE AVAILABLE. THE WAND IN QUESTION HAS BEEN DISCARDED BY THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT INDICATED NO DEFECTS ATTRIBUTABLE TO THE REPORTED MALFUNCTION. THIS LOT OF 200 PROBES WAS DISTRIBUTED BY INTACT BETWEEN NOV 2007 AND JAN 2008. NO SIMILAR REPORTS HAVE BEEN RECEIVED.

    Description of Event or Problem · 1

    IN 2008, A BREAST BIOPSY WAS PERFORMED USING INTACT BREAST LESION EXCISION SYSTEM (BLES). THE FIRST INTACT WAND USED (LOT NUMBER 626552) RESULTED IN AN EMPTY BASKET (NO SPECIMEN). THE SECOND INTACT WAND USED (LOT NUMBER 624215) STUCK OPEN AT MAXIMUM DIAMETER. PHYSICIAN INCREASED INCISION TO REMOVE WAND AND COMPLETED THE CASE AS A SURGICAL BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTACT BREAST LESION EXCISION SYSTEM INSTRUMENT, BIOPSY KNW INTACT MEDICAL 624215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other