BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING FORCEPS, 5MM W/CORD

    MDR report key: 2546627 · Received April 20, 2012

    Report

    Report Number
    2183680-2012-00027
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    February 15, 2012
    Report Date
    March 1, 2012
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED, THE CUTTING FORCEPS WAS RETURNED WITH CRACKED, FRACTURED FLARE, PIECES WERE NOT ACCOUNTED FOR. IT IS NOT KNOWN WHEN OR WHERE THE FRACTURED OCCURRED. WE HAVE NO INFORMATION AS TO HOW THE DEVICE WAS BEING USED AT THE TIME OF THIS OCCURRED. A REVIEW OF THE COMPLAINT DATA BASE DOES NOT INDICATE TRENDING OR A REOCCURRENCE OF THIS FAILURE MODE. WE ARE CONSIDERING THIS AN ISOLATED CAUSE AND WILL MONITOR THE COMPLAINT DATA BASE FOR FUTURE OCCURRENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATING RING AT THE DISTAL END WAS BROKEN. SURGERY WAS COMPLETED WITH A 2ND INSTRUMENT. AFTER INVESTIGATION OF THE INSTRUMENT, IT WAS FOUND THAT THE CUTTING FORCEPS HAD A CRACKED AND FRACTURED FLARE, PIECES WERE MISSING AND COULD NOT BE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING FORCEPS, 5MM W/CORD CUTTING FORCEPS GEI GYRUS MEDICAL, INC. 3006 387359KD

    Patients

    Seq Age Sex Outcome Treatment
    1