BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLASH BREAST BIOPSY DEVICE

    MDR report key: 1014394 · Received March 17, 2008

    Report

    Report Number
    3004014191-2008-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 14, 2008
    Manufacturer
    RUBICOR MEDICAL, INC.
    Product Code
    KNW
    PMA / PMN Number
    K071048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONICALLY STORED DATA WAS DOWNLOADED FROM THE DEVICE. DEVICE INVESTIGATION SUMMARY: THE ELECTRONICALLY STORED DATA FROM THE DEVICE REVEALED THAT THE DEVICE DID NOT RECYCLE ITSELF AS STATED BY THE PHYSICIAN, AND THIS PROBLEM COULD NOT BE CONFIRMED. COMPLETE FUNCTIONAL TESTING OF THE DEVICE COULD NOT BE PERFORMED BECAUSE OF MECHANICAL DAMAGE TO SEVERAL COMPONENTS. VISUAL INSPECTION OF THE DEVICE INDICATES THAT THE BROKEN TAB WAS CAUSED BY IMPROPER CLEARING OF THE TROCAR DURING THE HOMING CYCLE. BREAKAGE OF THE TAB IN THIS MANNER IS HIGHLY UNLIKELY TO CAUSE PT HARM BECAUSE A NON-FUNCTIONAL DEVICE WOULD RESULT AND THE FRAGMENT REMAINS IN THE ENCLOSED HANDLE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING THE BREAST BIOPSY OF A RELATIVELY HARD LESION, THE DEVICE FAILED TO DEPOSIT A SAMPLE AND RECYCLED ITSELF. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS OR HARM TO THE PT. EXAMINATION OF THE RETURNED DEVICE REVEALED THAT A SMALL FRAGMENT OF STAINLESS STEEL WAS MISSING FROM A TAB ON THE DEVICE. THE MISSING FRAGMENT WAS NOT FOUND ON THE DEVICE OR IN THE PACKAGING. THE PHYSICIAN WAS INFORMED ON 02/27/08. THE PT HAD ALREADY BEEN SCHEDULED FOR A FOLLOW-UP LUMPECTOMY. ON THE FOLLOWING MONTH, THE PHYSICIAN REPORTED THAT THE FRAGMENT WAS NOT FOUND IN THE PT OR THE EXCISED LESION. NO INJURY TO THE PT OR FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLASH BREAST BIOPSY DEVICE BIOPSY INSTRUMENT KNW RUBICOR MEDICAL, INC. 33209 08010302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other