BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EURO-MED

    MDR report key: 880278 · Received July 12, 2007

    Report

    Report Number
    1216677-2007-00014
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 12, 2007
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT BIOPSY TIP WAS RETURNED WITH THE BOTTOM PORTION OF THE JAW MISSING. BASED ON THIS, THE BELIEF IS THE TIP BROKE INSIDE THE PT REQUIRING THE PHYSICIAN TO REMOVE THE BROKEN PIECE FROM THE PT MANUALLY (FINGER OR FORCEPS). A VISUAL INSPECTION OF THE TIP REVEALED A BUILD OF BLOOD, TISSUE AND/OR CLEANING AGENT IN THE JAW MECHANISM. THIS BUILD UP DID NOT ALLOW FREE ACTIVATION OF THE JAW CONTRIBUTING TO THE TIP BREAKING.

    Description of Event or Problem · 1

    DURING A COLPOSCOPY PROCEDURE, THE BIOPSY TIP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO-MED ROTATING BIOPSY TIP KNW COOPERSURGICAL, INC. 64-484

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention