BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3913734 · Received July 3, 2014

    Report

    Report Number
    9680837-2014-00052
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 10, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. METHOD ¿ NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER: 07/11/2014. THE DEVICE WAS RETURNED FOR EVALUATION. THE PRODUCT ANALYSIS FOUND ¿ONE OF THE JAWS IS BROKEN NEXT TO THE STRIATIONS. THE FRAGMENT WAS NOT RETURNED BUT IT HAS BEEN RECOVERED BY THE HOSPITAL. NO MATERIAL OF MANUFACTURING DEFECT WAS FOUND. AN UNUSUAL CURVE IS OBSERVABLE NEXT TO THE BREAKAGE AREA. THE MOST PROBABLE CAUSE OF THIS BREAKAGE IS A SUCCESSION OF IMPORTANT EFFORTS [EXCESSIVE FORCE] ON THE JAW DURING THE USE OR THE REPROCESSING OF THE INSTRUMENT. THE CURVE INDICATES THAT THERE WAS AN IMPORTANT DEFORMATION OF THIS AREA BEFORE THE RUPTURE.¿ METHOD ¿ ACTUAL DEVICE EVALUATED; VISUAL INSPECTION. RESULTS - STRESS PROBLEM; FRACTURE PROBLEM. CONCLUSION ¿ OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, ¿ONE TIP OF THE [BIPOLAR] INSERT BROKE INTO THE ABDOMEN OF THE PATIENT. CLEANING DEPT NOTICED THAT BIPOLAR WAS BROKEN, THEY INFORMED THE SURGEON AND HE USED HIS ENDOSCOPIC CAMERA TO SEARCH THE BROKEN TIP WITHOUT SUCCESS. HE HAD TO USE FLUOROSCOPY TO FIND IT AND TO TAKE IT OUT OF THE PATIENT. LONGER ANESTHESIA.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389382 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV634-1A 130620

    Patients

    Seq Age Sex Outcome Treatment
    1