BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOTOME MR UNIVERSAL TARGETING SET

    MDR report key: 8344569 · Received February 15, 2019

    Report

    Report Number
    3008492462-2019-00008
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 17, 2019
    Report Date
    January 18, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    00841911101093
    PMA / PMN Number
    K042753
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAMMOTOME MR TARGETING SET CONSISTS OF A CRADLE, A SLEEVE MOUNT ASSEMBLY, AND AN OBTURATOR/STYLET FOR ACCURATE PROBE PLACEMENT USED TO PERFORM A BREAST TISSUE BIOPSY PROCEDURE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, WHICH PREVENTS A FULL INVESTIGATION AND ANALYSIS OF THE ROOT CAUSE AT THIS TIME. X-RAY IMAGE OF THE RETAINED BROKEN TIP WERE PROVIDED AND CONFIRM THE OBTURATOR PROXIMAL TIP BREAK. THE INSTRUCTIONS FOR USE (IFU) STATE: INSERT OBTURATOR/STYLET WITH DEPTH MARKINGS INTO SLEEVE WITH Z-LOCK; SET AND LOCK Z-DEPTH, ALIGNING BLACK TRIANGLE WITH TOP LINE OF OBTURATOR/STYLET; ORIENT THE CUBE; PLACE CUBE IN GRID; INSERT TARGETING ASSEMBLY INTO CUBE UP TO THE Z-LOCK. CAUTION: TO MINIMIZE THE RISK OF OBTURATOR BREAKAGE AT THE APERTURE, DO NOT TWIST OR TORQUE THE TARGETING SET DURING INSERTION. FOLLOW UP WITH THE RADIOLOGIST AT THE USER FACILITY IDENTIFIED THAT HE DID NOT FOLLOW THE IFU AND PLACED THE CUBE OVER THE TARGETING SET AND ATTEMPTED TO INSERT THE ENTIRE ASSEMBLY INTO THE GRID. THIS CAN CAUSE THE TARGETING SET TO BE INSERTED AT AN ANGLE, UNINTENTIONALLY CREATING A FULCRUM ON THE PROXIMAL END OF THE APERTURE. THE PATIENT UNDERWENT PREVIOUSLY SCHEDULED SURGERY TO REMOVE THE BREAST LESION AND OBTURATOR TIP. NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM SALES STATING, LEGACY MR BIOPSY OBTURATOR BROKE OFF INSIDE OF PATIENT'S BREAST DURING MR BIOPSY. THE PATIENT WAS TAKEN TO PREVIOUSLY SCHEDULED SURGERY TO HAVE THE BIOPSY AND THE TIP OF THE OBTURATOR REMOVED. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136387 MAMMOTOME MR UNIVERSAL TARGETING SET BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. MRU08X F11827477D 00841911101093

    Patients

    Seq Age Sex Outcome Treatment
    1