BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME - MAM 3008

    MDR report key: 2822844 · Received October 26, 2012

    Report

    Report Number
    MW5027482
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY LLC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A STEREOTACTIC RIGHT BREAST BIOPSY PROCEDURE, WHICH INCLUDED PLACEMENT OF A BREAST BIOPSY SITE IDENTIFIER AKA CLIP> WHEN THE SHEATH USED TO INSERT THE CLIP WAS REMOVED, THE PROVIDER NOTED THE DISTAL TIP OF THE SHEATH WAS MISSING AND THE CLIP WAS NOT DEPLOYED. IMAGING REVEALED A 1 CM BY 3 MM PIECE OF THE SHEATH REMAINED IN THE PT'S RIGHT BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME - MAM 3008 BIOPSY SITE IDENTIFIFER, AKA CLIP FZP ETHICON ENDO-SURGERY LLC MAM 3008 F11221138D1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other