BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 2896002 · Received November 20, 2012

    Report

    Report Number
    1820334-2012-00540
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 1, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNKNOWN AS LOT # IS UNKNOWN. (B)(4). MANUFACTURE DATE UNKNOWN AS LOT # IS UNKNOWN. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE HOOK BROKE OFF INSIDE THE PATIENT. THE CUSTOMER CONTACTED CUSTOMER SERVICE DURING THE PROCEDURE REQUESTING TO TALK WITH SOMEONE WHO COULD ADVISE HOW TO PROCEED. CUSTOMER SERVICE CONTACTED THE DISTRICT MANAGER AND TRANSFERRED THE CALL. PER THE DISTRICT MANAGER: THE PATIENT WAS IN SURGERY. THE DISTRICT MANAGER ADVISED THE SURGEON WHILE EXCISING THE LESION TO PROCEED AND REMOVE THE SPRING HOOK. THE SURGEON INQUIRED IF IT WAS SAFE TO LEAVE IN AND DISTRICT MANAGER ADVISED NOT TO AND TO REMOVE IT. THE SURGEON ADVISED SHE WOULD PROCEED. UPDATE ON (B)(6) 2012 - PER THE DISTRICT MANAGER: UNSURE WHY THE HOOK BROKE OFF, THE PATIENT WAS IN SURGERY, SO THE HOOK WAS REMOVED WHILE THERE. NO LOT NUMBER OBTAINED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DWO NEEDLE, BIOPSY, CARDIOVASCULAR DWO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK