BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FDR-1000BPY STEREO BIOPSY SYSTEM

    MDR report key: 4623246 · Received March 19, 2015

    Report

    Report Number
    2443168-2015-00002
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    January 7, 2013
    Report Date
    March 19, 2015
    Manufacturer
    FUJIFILM TECHNO PRODUCTS CO., LTD
    Product Code
    IZH
    PMA / PMN Number
    K113284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE ACTUALLY 2 DEVICES INVOLVED; THE STEREO BIOPSY POSITIONER ((B)(4) AND THE ASPIRE HD FFDM (AKA FDR-MS1000, S/N (B)(4), PRODUCT CODE MUE). THE FDR-1000BPY IS AN ACCESSORY FOR THE FDR-MS1000. THE UNITS ARE USED TOGETHER WHEN PERFORMING BIOPSIES. THE PATIENT WAS BEING PREPARED FOR A BIOPSY WHICH REQUIRES THE STEREO BIOPSY POSITIONER FOR LOCALIZATION OF THE BIOPSY AREA OF INTEREST. THE OPERATOR FAILED TO FOLLOW THE INSTRUCTIONS IN THE STEREO BIOPSY POSITIONER OPERATION MANUAL FOR ACHIEVING A MINIMUM COMPRESSION FORCE OF 60N ON THE ASPIRE HD FOR FULLY IMOBILIZING THE BREAST. THE COVER PAGE OF THE OPERATION MANUAL AND THE PAGE DESCRIBING THE COMPRESSION REQUIREMENT ARE PROVIDED AS PAGE 4 OF 5 AND 5 OF 5, RESPECTIVELY. .

    Description of Event or Problem · 1

    IT WAS DETERMINED DURING A RECENT FDA INSPECTION OF FUJIFILM MEDICAL SYSTEMS, U.S.A, INC. IN (B)(6) THAT THIS EVENT SHOULD BE REPORTED AS AN MDR. AN EMAIL DESCRIBING THE EVENT WAS RECEIVED BY THE MANUFACTURER FROM THE PHYSICIAN ON THE DATE OF THE EVENT: "I STARTED A STEREO BIOPSY ON A PATIENT TODAY AND WAS UNABLE TO DO IT, BECAUSE THE COMPRESSION WENT FROM 45 TO 19 DURING THE BIOPSY AND THE BREAST KEPT SLIPPING IN THE COMPRESSION PADDLE. I MADE A DEEP INCISION IN THE BREAST, BUT IT WAS IN THE WRONG PLACE AS THE BREAST SLIPPED OVER A FEW MINUTE PERIOD. WE REPOSITIONED THE PATIENT, BUT THE COMPRESSION KEPT DECREASING AND I WAS UNABLE TO PROCEED. SHE ASKED IF THERE WAS SOMETHING WRONG WITH THE EQUIPMENT (EMBARRASSING FOR ME) AND I TOLD HER THAT I WOULD HAVE THE (B)(6) EXPERT COME DURING THE BIOPSY. SHE IS ABLE TO COME ON (B)(6) (HER DAY OFF). YOU TOLD ME TO SCHEDULE THE BIOPSY AND THE EXPERT WOULD BE HERE, SO THAT IS WHAT I DID. PLEASE CONFIRM THIS DATE. THANK YOU. (B)(6). FUJIFILM MEDICAL SYSTEMS U.S.A, INC. (FMSU) DID NOT BELIEVE THIS EVENT WAS REPORTABLE FOR THE FOLLOWING REASONS: THE DEVICE DID NOT MALFUNCTION. IT OPERATED AS INTENDED AND THE USER DID NOT FOLLOW INSTRUCTIONS REGARDING ACHIEVING REQUIRED MINIMUM COMPRESSION FORCE OF 60N NECESSARY TO FULLY IMMOBILIZE THE BREAST. SEE ATTACHMENT A FOR THE APPLICABLE PAGES FROM THE OPERATOR'S MANUAL. THE DEVICE DID NOT CAUSE AN INJURY. THE PHYSICIAN ELECTED TO MAKE AN INCISION. INCISIONS ARE COMMONLY MADE WHEN PERFORMING BIOPSIES SO THAT THE NEEDLE DOES NOT TEAR THE SKIN WHEN BEING INSERTED AND REMOVED. THE INCISION IS TYPICALLY TREATED BY APPLYING A BANDAGE. WE DID NOT BELIEVE THE INCISION MET THE DEFINITION OF SERIOUS INJURY, AS IT WAS PART OF THE PROCEDURE. FMSU WILL SEEK THE OPINION OF A HEALTHCARE PROFESSIONAL AS TO WHETHER THIS EVENT WHEN CONSIDERING THAT AN INCISION WAS MADE BUT A BIOPSY WAS NOT PERFORMED, EVEN THOUGH THE INCISION WAS PART OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187466 FDR-1000BPY STEREO BIOPSY SYSTEM FULL FIELD MAMMOGRAPHY SYSTEM IZH FUJIFILM TECHNO PRODUCTS CO., LTD FDR-1000BPY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other