BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE

    MDR report key: 2576477 · Received August 12, 2010

    Report

    Report Number
    9610773-2010-00026
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    July 14, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT; HOWEVER, ONLY LIMITED INFO WAS PROVIDED. THE ELECTRODE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL REVEALED THAT THE LOOP CUTTING WIRE OF THE ELECTRODE WAS BROKEN AND THE TWO ENDS AT THE FRACTURE JOINT SHOWED EVIDENCE OF THERMAL DEFORMATION. THE REPORTED PHENOMENON APPEARS TO BE DUE TO EXCESSIVE ENERGY OUTPUT. THE ELECTRODE IS BEING FORWARDED TO THE ORIGINAL EQUIPMENT MFR FOR FURTHER EVAL. IF SIGNIFICANT ADD'L INFO IS REC'D, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC. IS FILING MDR'S ON BEHALF OF GYRUS (B)(4) AND OLYMPUS MEDICAL SYSTEMS CORPORATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF PROSTATE THE LOOP AT THE DISTAL END OF THE ELECTRODE BROKE IN TWO WHILE INSIDE OF THE PT. THE USER FACILITY PERSONNEL PROVIDED CONFLICTING INFO AS TO WHETHER THE DEVICE FRAGMENTS MAY OR MAY NOT HAVE FALLEN INTO THE PT. THE USERS REPORTEDLY USED A DIFFERENT ELECTRODE TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH FREQUENCY RESECTION ELECTRODE ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22302D NA

    Patients

    Seq Age Sex Outcome Treatment
    1