BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTICARE PLATINUM

    MDR report key: 1192430 · Received October 7, 2008

    Report

    Report Number
    1220984-2008-00002
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 31, 2008
    Report Date
    October 7, 2008
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INJURIES WERE REPORTED IN 2008, A HOLOGIC FIELD ENGINEER WAS DISPATCHED TO THE SITE ON THE NEXT DAY, TO EVALUATE THE MULTICARE PLATINUM SYSTEM IN QUESTION. THE FIELD ENGINEER FOUND NOTHING WRONG WITH THE SYSTEM, BUT DID REPLACE THE TABLETOP PORTION OF THE SYSTEM AT THE INSISTENCE OF THE CUSTOMER. THE CUSTOMER STATED THAT "THE DESIGN OF THE TABLETOP WAS WRONG". THE TABLETOP WAS REMOVED AND RETURNED TO THE MFG FACILITY FOR FURTHER EVAL. AN INSPECTION WAS COMPLETED BY A HOLOGIC QC INSPECTOR AND THE RESULTS WERE REVIEWED BY OUR MECHANICAL ENGINEERING MGR. THE EVAL SHOWED NO RELEVANT DISCREPANCIES WITH THE TABLETOP. THE MULTICARE PLATINUM WAS INSTALLED. USER TRAINING WAS PROVIDED BY A HOLOGIC APPLICATIONS SPECIALIST PRIOR TO USE ON PTS, HOWEVER, THE HOLOGIC SPECIALIST WAS NOT ALLOWED TO OBSERVE SITE PERSONNEL WHEN PERFORMING THE PROCEDURE ON ACTUAL PTS; OBSERVING THE USER PERFORM THE PROCEDURE ON INITIAL PTS IS PART OF THE NORMAL TRAINING PROCESS. HOLOGIC HAS SOLD MULTICARE PLATINUM SYSTEMS AND HAS NO OTHER REPORTS OF THIS KIND OF INJURY. HOLOGIC HAS CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM IS DUE TO USER ERROR. HOLOGIC OFFERED THE CUSTOMER ADDITIONAL TRAINING ON THE USE OF THE MULTICARE PLATINUM AT NO CHARGE TO THE CUSTOMER. THE OFFER WAS ACCEPTED AND THE TRAINING AND IS SCHEDULED TO OCCUR ON APPROX ONE MONTH AFTER THE ORIGINAL MONTH.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO HOLOGIC THAT TWO PTS REPORTED INJURIES AFTER HAVING BIOPSY PROCEDURES PERFORMED ON A MULTICARE PLATINUM SYSTEM. ONE INJURY OCCURRED ON PREVIOUS MONTH. IT IS UNK WHEN THE 2ND INJURY OCCURRED. ONE OF THE PTS REPORTED TO BE IN PAIN OR DISCOMFORT DURING THE PROCEDURE. SEVERAL DAYS AFTER THE PROCEDURE, BOTH PTS CONTACTED THE SITE AND REPORTED TO HAVE FRACTURED RIBS, AS A RESULT OF THE BIOPSY PROCEDURES. THE MULTICARE PLATINUM IS A BIOPSY DEVICE THAT REQUIRES THE PT TO LAY FACE-DOWN WHILE A BREAST IS POSITIONED THROUGH A HOLE IN THE TOP OF THE BIOPSY TABLE. IT SHOULD BE NOTED THAT BOTH PTS WERE WITH NO HISTORY OF OSTEOPOROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTICARE PLATINUM PRONE BIOPSY SYSTEM KNW HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other