BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYONS DISSECTING FORCEPS

    MDR report key: 2571416 · Received May 7, 2012

    Report

    Report Number
    2183680-2012-00029
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    December 22, 2011
    Report Date
    March 27, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K031080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED AND FOUND TO HAVE A FRACTURED HUB. THE BEST SHRINK TUBING WAS REMOVED FROM THE HUB AREA AND CONFIRMED THAT THE HUB WAS FRACTURED AT THE THIN TO THICK TRANSITION AREA OF THE PART. WHEN THE TWO PIECES WERE PLACED BACK TOGETHER THERE WERE NO PIECES MISSING ALL PARTS WERE ACCOUNTED FOR. WE CANNOT DETERMINE THE EXACT CAUSE OF THE FAILURE HOWEVER FAILURES SUCH AS THESE HAVE BEEN ATTRIBUTED TO EXCESSIVE LATERAL FORCE BEING APPLIED TO THE DISTAL END OF THE DEVICE BY THE USER. WE WILL CONTINUE TO MONITOR THE COMPLAINT DATA BASE FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUS (B)(4) THAT THE JAWS OF THE INSTRUMENT WERE INOPERATIVE. THE DEVICE WAS VISUALLY INSPECTED AND THE HUB WAS FOUND TO BE BROKEN. IT IS UNKNOWN AS TO WHEN OR HOW THE DEVICE BROKE. THE DEVICE ALSO SHOWS SOME POSSIBLE TISSUE OR FLUID ON THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYONS DISSECTING FORCEPS DISSECTING FORCEPS GEI GYRUS MEDICAL INC. 3700 369446JD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK