BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HF-RESECTION ELECTRODES

    MDR report key: 1874370 · Received October 12, 2010

    Report

    Report Number
    9610773-2010-00037
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    March 18, 2010
    Report Date
    September 16, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. IT WAS REPORTED THAT THE ELECTRODE LOOP BROKE DURING A CO2 LASER LAPAROSCOPY WITH ENTEROLYSIS ADHESIOLYSIS LAPAROSCOPIC MYOMECTOMY, HYSTEROSCOPIC MYOMECTOMY, WITH DILATORY CURETTAGE. THE PHYSICIAN WAS UNABLE TO DETERMINE IF A PIECE OF THE LOOP HAD FALLEN INTO THE PT BUT RESPONDED AS IF THERE WAS. THE PHYSICIAN IRRIGATED THE AREA AND IT WAS REPORTEDLY ASSUMED THAT IF A PIECE HAD FALLEN INTO THE PT, IT WOULD HAVE BEEN WASHED OUT. THERE WAS NO PT INJURY AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT BUT SIMILAR DEVICE. NO OTHER EQUIPMENT WAS REPLACED DURING THE PROCEDURE. THE DEVICE REFERRED TO THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE DEVICE WAS RETURNED IN A BIOHAZARDOUS CONDITION, WHICH LIMITED THE EVAL TO INSPECTION ONLY. THE EVAL CONFIRMED THAT THE ELECTRODE CUTTING LOOP WAS BROKEN OFF, AND THE RETURNED PORTION APPEARED TO INDICATE PHYSICAL SHEARING AT THE FRACTURE JUNCTIONS. THE DEVICE WILL BE FORWARDED TO OEM FOR FURTHER INVESTIGATION. IF SIGNIFICANT ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC. IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE ELECTRODE LOOP BROKE DURING A GYNECOLOGICAL PROCEDURE, BUT THE USERS COULD NOT ASCERTAIN IF ANY DEVICE FRAGMENTS FELL INTO THE PT. THE PHYSICIAN REPORTEDLY IRRIGATED THE AREA. THE ELECTRODE WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HF-RESECTION ELECTRODES RESECTION ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA47051C NA

    Patients

    Seq Age Sex Outcome Treatment
    1