BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VISERA LAPARO-THORACO VIDEOSCOPE

    MDR report key: 3823877 · Received March 3, 2014

    Report

    Report Number
    8010047-2014-00077
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN MATERIALS WERE DISPOSED AT THE FACILITY. THE SUBJECT DEVICE EXPECT THE FOREIGN MATERIAL RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE GLUE OF THE BOTH SIDE OF THE BENDING SECTION WERE MISSING. THE SUBJECT DEVICE WAS MANUFACTURED IN 2006 AND THERE WAS NO IRREGULARITY IN THE MANUFACTURING RECORD. OMSC CONCLUDED THAT THE SEPARATION OF THE GLUE HIGHLY OCCURRED WHEN THE USER FACILITY FORCIBLY WITHDREW THE SUBJECT DEVICE FROM THE TROCAR WITH THE SUBJECT DEVICE ANGULATED. THE DEVICE INSTRUCTION MANUAL WARNS USERS THAT "WHEN WITHDRAWING THE ENDOSCOPE FROM THE TROCAR TUBE, MAKE SURE TO STRAIGHTEN THE BENDING SECTION AND WITHDRAW IT VIEWING THE ENDOSCOPIC IMAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE DOCTOR FOUND BLACK FOREIGN MATERIALS IN THE PATIENT. THE DOCTOR REPORTEDLY RETRIEVED ALL OF THE MATERIALS FROM THE PATIENT AND FOUND THE MATERIAL WERE PARTS OF BENDING SECTION OF THE SUBJECT DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO OTHER PATIENT INJURY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128396 OLYMPUS VISERA LAPARO-THORACO VIDEOSCOPE LAPARO-THORACO VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORPORATION LTF-VP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK