BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOTOME EX BIOPSY SYSTEM

    MDR report key: 8741337 · Received June 27, 2019

    Report

    Report Number
    3008492462-2019-00029
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 27, 2019
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    UDI-DI
    10841911100949
    PMA / PMN Number
    K033700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 OBTAIN TISSUE SAMPLES FROM THE BREAST FOR DIAGNOSTIC ANALYSIS OF BREAST ABNORMALITIES. THE DEVICE WAS RETURNED TO DEVICOR MEDICAL PRODUCTS, INC. FOR EVALUATION. THE DEVICE WAS RECEIVED IN TWO PIECES. USER REPORTED THAT THE DEVICE WAS REMOVED FROM THE PHYSICIAN'S FINGER BY CUTTING THE PROBE WITH A CAST SAW. OUR EVALUATION NOTED PIECES OF GLOVE FOUND TWISTED AROUND THE CUTTER. THE PROBE IS CUT THROUGH THE TISSUE COLLECTION AREA WHICH CUT THROUGH THE CUTTER, LOWER LUMEN, AND THE PROBE HOUSING. THE CUTTER IS FORWARD APPROXIMATELY 1.6 INCHES FROM THE SAMPLING AREA BUT NOT VISIBLE IN THE APERTURE. MULTIPLE ATTEMPTS WERE MADE TO GET ADDITIONAL INCIDENT INFORMATION FROM THE USER FACILITY WITHOUT SUCCESS. THEY REPORT THAT THE PHYSICIAN IS DOING WELL. NO INFORMATION PROVIDED REGARDING MEDICAL INTERVENTION REQUIRED. WITHOUT FURTHER INCIDENT DETAILS WE ARE NOT ABLE TO DETERMINE ROOT CAUSE FOR THE REPORTED INCIDENT. INSTRUCTIONS FOR USE STATE: "STERILE FORCEPS MAY BE USED TO AID IN REMOVING THE SPECIMEN FROM THE KNOCKOUT TUBE OR DISTAL END OF THE SPECIMEN COLLECTION CHAMBER". AND WARN: "DO NOT PLACE ANY INSTRUMENTS OR OBJECTS IN THE SPECIMEN COLLECTION CHAMBER WHEN THE CUTTER IS MOVING".

    Description of Event or Problem · 1

    DEVICOR MEDICAL PRODUCTS, INC. RECEIVED A REPORT FROM A USER FACILITY STATING, "DURING THE PROCEDURE THE PHYSICIAN HAD HER FINGER STUCK IN THE EX PROBE BETWEEN THE CUTTER AND THE END OF THE COLLECTION CHAMBER. SHE WAS UNABLE TO REMOVE HER FINGER, THE CUTTER WAS ADVANCED FORWARD AND LODGED SO HER FINGER COULD NOT BE REMOVED. WHEN IT JAMMED THEY HAD AN ERROR ON THE DEVICE SO THEY SHUT IT OFF AND REMOVED THE PROBE FROM THE BREAST." THE USER CONTACTED DEVICOR FOR INFORMATION ON HOW TO REMOVE THE PROBE FROM THE PHYSICIAN'S FINGER. THE USER WAS INSTRUCTED TO REMOVE THE PROBE FROM THE HOLSTER AND ADVISED TO SEEK ASSISTANCE WITH REMOVAL OF THE PROBE FROM THE PHYSICIAN'S FINGER IN THE EMERGENCY DEPARTMENT. THE PROBE WAS REMOVED FROM THE PHYSICIAN'S FINGER IN THE EMERGENCY ROOM. THIS HAS BEEN DOCUMENTED IN OUR SYSTEMS AS RECORD # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533630 MAMMOTOME EX BIOPSY SYSTEM BIOPSY INSTRUMENT KNW DEVICOR MEDICAL PRODUCTS, INC. HH11BEX F11908410D 10841911100949

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention