BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOTOME EX BIOPSY SYSTEM

    MDR report key: 8800033 · Received July 17, 2019

    Report

    Report Number
    3008492462-2019-00034
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 21, 2019
    Report Date
    July 17, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    10841911100956
    PMA / PMN Number
    K033700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED THE DEVICE FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE HAS BEEN COMPLETED AND IT WAS CONFIRMED THAT THE TIP OF THE PLASTIC COMPONENT (KO TIP) IS MISSING FROM THE METALLIC LINE (KO LINE). THE KO TIP IS NEVER INTRODUCED IN THE PATIENT. THE FUNCTION OF THIS TIP IS TO EXPEL THE TISSUE INSIDE THE CUTTER TO THE COLLECTION CHAMBER; THE ONLY WAY TO INTRODUCE THE TIP INSIDE THE PATIENT IS IF THE TIP WAS SHEARED OFF BY THE CUTTER DURING THE TRANSLATION OR THE TIP WAS SHEARED OFF ACCIDENTALLY MANUALLY AND UNINTENTIONALLY PLACED IN THE PATHWAY OF THE CUTTER, PASSING THROUGH THE NEEDLE. FUNTIONAL TESTING WAS CONDUCTED AT THE MANUFACTURING SITE TO ATTEMPT TO DUPLICATE THE FAILURE WITH NO SUCCESS. THE MANUFACTURING PROCESS WAS REVIEWED AND NO AREAS WERE IDENTIFIED THAT COULD SHEAR THE KO TIP. BASED UPON THE RETURNED SAMPLE EVALUATION AND MANUFACTURING PROCESS REVIEW, NO DIRECT CAUSE OR ROOT CAUSE COULD BE DETERMINED FOR THE SHEARING OF THE KO TIP.

    Additional Manufacturer Narrative · 1

    THE MAMMOTOME EX PROBE IS A STERILE, SINGLE PATIENT USE INSTRUMENT THAT MAY BE USED WITH IMAGING GUIDANCE, SUCH AS ULTRASOUND, TO EXCISE A DIAGNOSTIC SAMPLE FROM THE BREAST OR AXILLARY LYMPH NODES FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. DEVICE EVALUATION IS ANTICIPATED, HOWEVER DEVICOR MEDICAL PRODUCTS, INC. HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION. BASED ON THE FACT THAT THERE WAS AN UNINTENDED PIECE OF THE DEVICE LEFT IN THE PATIENT BREAST AND PURSUANT TO 21 CFR 803, WE ARE SUBMITTING THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM AFFILIATE, DEVICOR MEDICAL (B)(4) LTD., STATING, THE EQUIPMENT WAS OPERATING NORMALLY, THE CAPITAL AND THE PROBE WERE CONNECTED. DURING THE PROCEDURE, WHEN THE USER PRESSED THE BIOPSY BUTTON, THE PLASTIC PART OF THE SPECIMEN COLLECTION CHAMBER WAS BROKEN AND GOT INTO THE PATIENT'S BREAST. THE USER WAS ABLE TO IDENTIFY THE PIECE USING ULTRASOUND AND REMOVE THIS PART AT THE NEXT BREAST TISSUE BIOPSY. THIS HAS BEEN DOCUMENTED IN OUR SYSTEM AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592666 MAMMOTOME EX BIOPSY SYSTEM MAMMOTOME EX BIOPSY SYSTEM KNW DEVICOR MEDICAL PRODUCTS, INC. HH8BEX F11911495D 10841911100956

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention