BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGATING DEVICE

    MDR report key: 3973275 · Received June 6, 2014

    Report

    Report Number
    8010047-2014-00320
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT THE LOOP REMAINED IN THE DISTAL END OF THE COIL SHEATH OF THE DEVICE. THERE WERE NO ABNORMALITIES FOUND UPON INVESTIGATION OF THE OTHER PARTS ALSO AS THE RESULT OF CHECKING THE MFG RECORD OF THE SAME LOT NOTHING ABNORMAL DETECTED. THEREFORE, OMSC CONSIDERS THAT USER HANDLING CAUSED THIS PHENOMENON. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT THERE IS POSSIBILITY THE LOOP CANNOT BE DETACHED FROM THE DEVICE AND IT ALSO DESCRIBES WHAT TO DO IF THE LOOP CANNOT BE DETACHED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING RESECTION OF COLON POLYP, THE LOOP COULD NOT BE DETACHED FROM THE DEVICE. THE DOCTOR CUT THE INSERTION PORTION NEAR HANDLE OF THE DEVICE. IN ADDITION, HE WITHDREW AND REINSERTED THE ENDOSCOPE INTO THE PT AND CUT THE LIGATED POLYP BY USING ELECTROSURGICAL SNARE. HE COULD REMOVE THE DEVICE AND THE LOOP FROM THE PT AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY REGARDING THIS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331207 LIGATING DEVICE LIGATING DEVICE (POLY LOOP) GEI OLYMPUS MEDICAL SYSTEMS CORPORATION HX-20U-1 K2719

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR