BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCEPS

    MDR report key: 3242181 · Received July 19, 2013

    Report

    Report Number
    3242181
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    August 8, 2012
    Report Date
    July 19, 2013
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Product Code
    BWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOPSY FORCEP WAS INSERTED DURING BRONCHOSCOPY TO OBTAIN SPECIMENS. AFTER IT WAS OPENED TO OBTAIN THE SPECIMEN, IT WOULD NOT CLOSE TO GRASP THE SPECIMEN. THE FORCEP WAS REMOVED FROM THE PATIENT IN THE OPEN POSITION AND THEN THE FORCEP HAD TO BE CUT TO BE REMOVED FROM THE BRONCHOSCOPE. THE PATIENT HAD TO HAVE THE BRONCHOSCOPE REINSERTED, A SECOND FORCEP WAS INSERTED AND BIOPSY WAS OBTAINED. NO APPARENT HARM TO PT. 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 BIOPSIES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338076 BIOCEPS FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID) BWH ENDO-THERAPEUTICS, INC. * 70697

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR NO OTHER THERAPIES