BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3242183

    MDR report key: 3242183 · Received July 19, 2013

    Report

    Report Number
    3242183
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 19, 2013
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING BIOPSIES WITH THE USE OF THE BIOCEPS FORCEPS WHICH WAS PASSED INSIDE THE BRONCHOSCOPE. AFTER A COUPLE OF BIOPSIES WERE OBTAINED, THE BIOCEP FORCEP WAS REINSERTED INTO THE BRONCHOSCOPE. THE PHYSICIAN DIRECTED THE RESPIRATORY THERAPIST TO OPEN AND CLOSE THE FORCEP TO OBTAIN THE SPECIMEN AND WHEN IT WAS BEING CLOSED BY THE RESPIRATORY THERAPIST THE PHYSICIAN FELT AS IF IT HAD POPPED AND COULD FEEL IT VIBRATE THROUGH THE SCOPE. THE FORCEP WAS KEPT AS CLOSED AS IT COULD SINCE IT WOULD NOT CLOSE COMPLETELY. THE BRONCHOSCOPE HAD TO BE PULLED OUT WITH THE FORCEP AND BIOPSY INTACT INSIDE THE SCOPE. ONCE THE FORCEP WAS OUT AND THE BIOPSY WAS REMOVED THE FORCEP WAS CUT SO IT COULD BE REMOVED FROM THE BRONCHOSCOPE. NO PATIENT HARM. THERE HAVE BEEN TWO SIMILAR EVENTS WITH THIS TYPE OF EQUIPMENT AT THIS FACILITY IN THE LAST MONTH.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BRONCHOSCOPY WITH BIOPSY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO OTHER THERAPIES