BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 3941532 · Received April 17, 2014

    Report

    Report Number
    8010047-2014-00191
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 7, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE MANIPULATION WIRE WAS COME AWAY FROM THE CUP AND DEFORMED. THE DISTAL END OF THE WIRE WAS BROKEN. THERE WAS DAMAGE ON THE CUP WHICH MIGHT OCCUR WHEN THE MANIPULATION WIRE COME AWAY FROM THE CUP. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, NOTHING ABNORMAL DETECTED. THUS, OMSC CONSIDERS THAT WITHDRAWING THE SUBJECT DEVICE WHILE THE ENDOSCOPE WAS ANGULATED CAUSED THE BREAKAGE OF THE MANIPULATION WIRE. THIS REPORT IS BEING SUBMITTED AS A MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP (OMSC) WAS INFORMED THAT DURING BRONCHOSCOPY THE DOCTOR OPENED CUPS BUT ONE CUP COULD NOT OPEN. THE DOCTOR COMPLETED PROCEDURE USING ANOTHER DEVICE. THE DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. DURING THE INVESTIGATION, OMSC FOUND THE DISTAL END OF THE MANIPULATION WIRE WAS PARTIALLY MISSING. AFTER THE PROCEDURE, THE DOCTOR PERFORMED X-RAY EXAMINATION AND THERE WAS NON ABNORMALITY. THERE WAS NO REPORT OF PT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236499 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS FCL OLYMPUS MEDICAL SYSTEMS CORPORATION FB-211D T36105

    Patients

    Seq Age Sex Outcome Treatment
    1