BEUDAMED
    FDA Adverse Event Other Summary report: N

    DFX-G

    MDR report key: 3536598 · Received November 8, 2013

    Report

    Report Number
    3007024186-2013-00001
    Event Type
    Other
    Date Received
    November 8, 2013
    Date of Event
    October 2, 2013
    Report Date
    November 11, 2013
    Manufacturer
    ELLIQUENCE LLC
    Product Code
    GEI
    PMA / PMN Number
    K061174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 A PROCEDURE WAS CONDUCTED ENDOSCOPIC LUMBAR DISCECTOMY) ON A PATIENT ((B)(6)) FOR THE PURPOSE OF REMOVING DISC FRAGMENTS AT THE L4-L5, L5-S1 LUMBAR LEVELS. THE PROCEDURE WAS PERFORMED BY DR (B)(6)USING PITUITARY FORCEPS FOR THE REMOVAL OF SOFT TISSUE WITHIN THE SURGICAL AREA. THE PITUITARY FORCEPS HAVE A WORKING JAW SYSTEM IN WHICH THE LOWER JAW REMAINS STATIONARY AND THE UPPER JAW PROVIDING A GRASPING ACTION FOR SOFT TISSUE. DURING THE PROCEDURE, THE BOTTOM JAW OF THE FORCEP BROKE OFF FROM THE INSTRUMENT ASSEMBLY INTO THE BODY OF THE PATIENT AT THE L5-S1 LEVEL. THE SURGEON INVOLVED COULD NOT REMOVE THE JAW SEGMENT FROM THE PATIENT AND DECIDED TO CLOSE THE SURGICAL AREA IN CONCLUSION OF THE PROCEDURE FEELING THAT THE JAW SEGMENT WAS SECURE IN THE PATIENT'S BODY AND POSED NO RISK TO THE PATIENT AT THE TIME. ELLIQUENCE RECEIVED WRITTEN CONFIRMATION OF THE INCIDENT ON (B)(6) 2013. THE PRODUCT WAS SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS. THE SUPPLIER'S FINAL INVESTIGATION RESULTS WILL DETERMINE THE NEXT STEPS TO CONCLUDE AND CLOSE THIS EVENT. THERE IS NO UNDERSTANDING AT THIS TIME AS TO HOW THE LOWER JAW SEPARATED FROM THE ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579643 DFX-G GRASPING FORCEPS GEI ELLIQUENCE LLC DFX-G 20345

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization