BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 6762183 · Received August 2, 2017

    Report

    Report Number
    2951238-2017-00507
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 14, 2017
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    PK051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDF TO FDS.

    Additional Manufacturer Narrative · 1

    THE SCOPE AND THE BIOPSY CAP WERE RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE REPORTED EVENT. A VISUAL INSPECTION FOUND THE RUBBER CAP DAMAGED. IN ADDITION, THE SCOPE¿S BIOPSY CHANNEL WAS FOUND LEAKING. THERE WAS A TEAR MARK FOUND INSIDE THE BIOPSY CHANNEL WALL THAT LIKELY CONTRIBUTED TO THE LEAK. THE LIGHT GUIDE LENS WAS ALSO FOUND CRACKED. THE SCOPE WAS SERVICED AND RETURNED TO THE USER FACILITY. BASED ON THE EVALUATION FINDINGS, THE CAUSE OF THE DAMAGED BIOPSY CAP IS LIKELY DUE TO USER HANDLING / EXCESSIVE FORCE WHEN INSERTING AN ACCESSORY INSTRUMENT THROUGH THE BIOPSY CAP. THE INSTRUCTION MANUAL FOR USE PROVIDES WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE BIOPSY CAP. ¿SLOWLY INSERT OR WITHDRAW THE ENDOTHERAPY ACCESSORY STRAIGHT INTO OR FROM THE SLIT OF THE BIOPSY VALVE. OTHERWISE, THE BIOPSY VALVE MAY BE DAMAGED AND PIECES OF IT COULD FALL OFF. INSERTING OR WITHDRAWING ENDOTHERAPY ACCESSORIES WITH EXCESSIVE FORCE MAY DAMAGE THE INSTRUMENT CHANNEL OR ENDOTHERAPY ACCESSORIES AND COULD CAUSE SOME PARTS TO FALL OFF AND/OR CAUSE PATIENT INJURY.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TOWARDS THE END OF AN UPPER ENDOSCOPY PROCEDURE, A SMALL DEVICE FRAGMENT (BIOPSY CAP) WAS FOUND INSIDE THE PATIENT¿S STOMACH. THE DEVICE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME SCOPE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542543 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-2TH180 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1