BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER RONGEUR

    MDR report key: 1242803 · Received November 13, 2008

    Report

    Report Number
    1242803
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 13, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE NEUROSURGERY RESIDENT WAS USING THE STRAIGHT MICRO PITUITARY RONGEUR FOR GRASPING TISSUE, WHEN THE TOP PART OF THE INSTRUMENT (APPROX. 1 CM) BROKE OFF INSIDE THE PATIENT. BOTH THE RESIDENT AND THE ATTENDING SURGEON UNSUCCESSFULLY SEARCHED FOR THE BROKEN PIECE IMMEDIATELY. THEY THEN CONTINUED WITH THE OPERATION. AT THE END OF THE SURGICAL PROCEDURE, THE MISSING PART WAS AGAIN VISUALIZED IN THE BACK OF THE THROAT VIA FLUOROSCOPY. FLUOROSCOPY WAS PERFORMED INTERMITTENTLY DURING THE CASE. THE ANESTHESIA TEAM THEN ATTEMPTED TO RETRIEVE THE MISSING PART OF THE INSTRUMENT UNSUCCESSFULLY. THE MISSING PART CONTINUED DOWN THE ESOPHAGUS. FLUOROSCOPY AND X-RAYS CONFIRMED THE LOCATION OF THE PIECE IN THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECKER RONGEUR RONGEUR, ALLIGATOR ACTION HTX CODMAN & SHURTLEFF, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR