BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 1842916 · Received September 17, 2010

    Report

    Report Number
    1820334-2010-00471
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 25, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL PROCEDURE. ALTHOUGH THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION, THE CUSTOMER DID RETURN A TOTAL OF 15 UNUSED DEVICES. THE RETURNED DEVICES WERE UNUSED DEVICES AS SUCH THEY DO NOT AID IN IDENTIFICATION OF ROOT CAUSE. PER QUALITY CONTROL SPECIFICATION, THIS DEVICE IS INSPECTED 100% DURING MANUFACTURING AND PRIOR TO ANY FURTHER PROCESSING. THE DEVICE IS SHIPPED WITH AN IFU, IN WHICH IT IS STATED: "UNDER NO CIRCUMSTANCES SHOULD A HOOK WIRE ENGAGED IN TISSUE BE PULLED OUT WITHOUT SURGICAL INTERVENTION." THE IFU ALSO CAUTIONS THAT "FOLLOWING PLACEMENT OF THE HOODWIRE, THE PORTION PROTRUDING OUTSIDE OF THE BREAST SHOULD BENT AND TAPED TO THE SKIN TO PREVENT INADVERTENT MOVEMENT." THE IFU ALSO ADDS: "THE HOOK WIRE SHOULD BE USED AS A GUIDE FOR THE SURGEON, NOT A RETRACTOR." WITHOUT THE RETURN OF THE ACTUAL COMPLAINT DEVICE, IT WILL NOT BE POSSIBLE TO MAKE AN INFORMED JUDGMENT AS TO THE CAUSE OF THE SEPARATION. WHETHER THIS SCENARIO CONTRIBUTED TO THE COMPLAINT IS UNKNOWN AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    INCIDENT OCCURRED ON AUGUST 19TH. A 5CM KOPANS WIRE WAS INSERTED FOR MAMMOGRAPHY WIRE LOCALIZATION. THE TIP OF THE WIRE BROKE OFF FROM THE MAIN PART OF THE WIRE INSIDE THE BREAST. THE TIPS WERE SURGICALLY REMOVED AND THERE WERE NO SIDE EFFECTS TO THE PATIENT. THE NEEDLE BROKE AT PLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY SIDE 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 2519478

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention