BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPSY FORCEPS

    MDR report key: 3240234 · Received July 16, 2013

    Report

    Report Number
    8010047-2013-00197
    Event Type
    Other
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PART OF THE SUBJECT DEVICE WAS BROKEN AT THE DISTAL PART AND THE CUP COULD NOT BE OPERATED. THE PART WAS BENT AT THE BROKEN POINT AND THE DISTAL END OF THE SUBJECT DEVICE WAS DEFORMED. THERE WAS NO ABNORMALITY IN THE MANUFACTURING RECORD OF THE SUBJECT DEVICE. OMSC CONCLUDED THAT THE EXCESSIVE FORCE CAUSE THE PHENOMENON. THE EXCESSIVE FORCE WAS LIKELY ADDED TO THE SUBJECT DEVICE DURING INSERTION OF THE SUBJECT DEVICE INTO THE SCOPE CHANNEL WHILE THE ELEVATOR WAS OPERATED TO THE UP POSITION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP (OMSC) WAS INFORMED THAT DURING AN ESOPHAGO GASTRO DUODENOSCOPY, THE FACILITY TRIED TO COLLECT A TISSUE USING THE SUBJECT DEVICE, HOWEVER THE DISTAL END OF THE SUBJECT DEVICE BROKE AND THE FACILITY COULD NOT CLOSE THE CUPS OF THE SUBJECT DEVICE. THE FACILITY REPORTEDLY ABANDONED THE PROCEDURE AND COULD WITHDRAW THE SUBJECT DEVICE WITH THE DUODENOSCOPE, HOWEVER THE MUCOSA OF THE ESOPHAGUS WALL WAS INJURED. IT WAS REPORTED THAT FACILITY TREATED THE INJURED WALL WITH SEVEN PIECES OF CLIPS TO PREVENT BLEEDING. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328044 BIOPSY FORCEPS BIOPSY FORCEPS KNW OLYMPUS MEDICAL SYSTEMS CORPORATION FB-40Q-1 K2824

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other