BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HIGH FREQUENCY ELECTRODE

    MDR report key: 2010336 · Received February 11, 2011

    Report

    Report Number
    9610773-2011-00006
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 14, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L DETAILED INFO REGARDING THE EVENT, AND WAS INFORMED THAT THE SUBJECT DEVICE (ELECTRODE) WAS USED IN A THERAPEUTIC UROLOGY PROCEDURE, AND THE USER EXPERIENCED RESTRICTION AT THE DISTAL END OF THE RESECTOSCOPE UPON INSERTION OF THE ELECTRODE. THE ELECTRODE WAS WITHDRAWN FROM THE RESECTOSCOPE AND FOUND THAT THE LOOP WIRE BROKE IN HALF, BUT BOTH OF THE LOOP WIRES REMAINED ATTACHED TO THE ELECTRODE SHAFT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT, BUT SIMILAR ELECTRODE. THE CLINICAL ENGINEER FURTHER REPORTED THAT THERE WAS NO PROBLEM WITH THE RESECTOSCOPE AND WORKING ELEMENT. THERE WAS NO PT INJURY REPORTED. THE USER FACILITY RETURNED THE RESECTION ELECTRODE (SUBJECT DEVICE) ALONG WITH THE RESECTOSCOPE AND WORKING ELEMENT TO OLYMPUS FOR EVAL; THESE INSTRUMENTS WERE RECEIVED IN A BIOHAZARD BAG, WHICH LIMITED THE EVAL TO A VISUAL INSPECTION. THERE WAS EVIDENCE OF BIOMATERIALS AND STAIN ON THE EXTERNAL SURFACE OF THE ELECTRODE. THE LOOP WIRE WAS CRACKED AND WAS BROKEN IN HALF. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE ELECTRODE WAS FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER INVESTIGATION. IF ADD'L SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT (MDR) IN AN ABUNDANCE OF CAUTION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, "THE ELECTRODE LOOP HAD A BREAK IN IT. THERE WAS PT INVOLVEMENT, BUT NO INJURY TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH FREQUENCY ELECTRODE ELECTRODE GEI OLYMPUS WINTER & IBE GMBH A22201C 102W28

    Patients

    Seq Age Sex Outcome Treatment
    1 RESECTOSCOPE MODEL A22002A WITH LOT # 10K| WORKING ELEMENT MODEL A2761 WITH LOT #07W| WORKING ELEMENT MODEL A2761 WITH LOT #07W| RESECTOSCOPE MODEL A22002A WITH LOT # 10K