BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EURO-MED

    MDR report key: 921098 · Received October 3, 2007

    Report

    Report Number
    1216677-2007-00026
    Event Type
    Malfunction
    Date Received
    October 3, 2007
    Date of Event
    September 18, 2007
    Report Date
    October 3, 2007
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOPSY PUNCH WAS OBSERVED TO HAVE SOME BLOOD RUST AND/OR CORROSION FROM FAILING TO COMPLETELY REMOVE BLOOD, TISSUE AND CLEANING AGENTS FROM THE INSTRUMENT PRIOR TO AUTOCLAVING. THE BIOPSY PUNCH BROKE AT THE BASKET PINS INDICATING EXCESS FORCE WAS APPLIED TO THE INSTRUMENT DURING USE. BOTH THE CORROSION AND EXCESS FORCE WERE FACTORS IN THE BREAKAGE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    DURING A CERVICAL BIOPSY, THE BIOPSY PUNCH BROKE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO-MED MINI TOWNSEND BIOPSY PUNCH KNW COOPERSURGICAL, INC. 64-690

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention