BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHMOID FORCEPS STRAIGHT

    MDR report key: 1547910 · Received November 20, 2009

    Report

    Report Number
    1418479-2009-00017
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 7, 2009
    Report Date
    November 20, 2009
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 8211.09 - ETHMOID FORCEPS STRAIGHT - LOT #: UNK. THE ETHMOID FORCEPS WERE INSPECTED AND BROKEN JAW WAS CONFIRMED. THE BROKEN JAW WAS NOT INCLUDED IN THE RETURNED PACKAGE. WE DO NOT KNOW IF IT WAS DISCARDED WITHIN OUR FACILITY, OR AT THE USER FACILITY. THE ETHMOID FORCEPS IS, FROM APPEARANCE, 10 PLUS YEARS OLD. THE ETHMOID FORCEPS ARE DESIGNED TO GRASP, NOT CUT TISSUE. THE TISSUE IS REMOVED BY GRASPING AND PULLING IT GENTLY AWAY FROM THE MUSCOSA OR BONE. CAUSE: USE AND HANDLING WITH EXCESS FORCE APPLIED TO THE JAW DURING USE.

    Description of Event or Problem · 1

    DURING A SINUS PROCEDURE (LANDMARX IMAGE GUIDED FESS), THE JAW BROKE. THE JAW PIECE AND FORCEPS WERE COLLECTED FOR RETURN TO MANUFACTURER. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHMOID FORCEPS STRAIGHT ETHMOID FORCEPS STRAIGHT JXX RICHARD WOLF GMBH 8211.09 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR