BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A CORD

    MDR report key: 3958438 · Received June 13, 2014

    Report

    Report Number
    8010047-2014-00310
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 19, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE CABLE BROKE NEAR A CODE PLUG. THE CABLE CORE WAS BURNT AND THE BROKEN OUT SECTION WAS DISCOLORED. OMSC WAS INFORMED THAT THE USER FACILITY HAD USED THE SUBJECT DEVICE FOR NEARLY 10 YEARS. OMSC ASSUMES THAT BENDING LOAD WAS PUT ON THE CABLE REPEATEDLY OVER LONG PERIODS AND IT CAUSED THE BREAKAGE OF THE CABLE CORE. IN ADDITION, THE USER FACILITY CONTINUED TO USE THE SUBJECT DEVICE WITH THE CABLE CORE BROKEN, IT CAUSED THIS EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVIC REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING POLYPECTOMY OF COLON THE DOCTOR GOT AN ERROR TRYING TO ACTIVATE OUTPUT WHILE HE SNARED THE TARGET POLYP AND OUTPUT COULD NOT BE ACTIVATED . THEN HE NOTICED THAT THE SUBJECT PRODUCT BROKE. HE EXCHANGED THE SUBJECT PRODUCT AND THE ELECTROSURGICAL UNIT FOR OTHER DEVICES AND COMPLETED THE PROCEDURE. THERE WAS NO REPAIR OF PATIENT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349882 A CORD A CORD FFZ OLYMPUS MEDICAL SYSTEMS CORPORATION MH-969 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1