BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HF RESECTION ELECTRODES

    MDR report key: 2114111 · Received May 6, 2011

    Report

    Report Number
    9610773-2011-00014
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 7, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT, HOWEVER, NO ADD'L DETAILED INFO REGARDING THE REPORTED EVENT WAS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND THE RED PROTECTION TUBE SHEATH AND THE CONTACT PIN WERE COMPLETELY WITHDRAWN FROM THE STABILIZING TUBE AND DAMAGED. THE REPORTED PHENOMENON WAS ATTRIBUTED TO PHYSICAL DAMAGE DUE TO HANDLING. THE SUBJECT DEVICE WILL BE FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER INVESTIGATION. IF SIGNIFICANT ADD'L INFO IS RECEIVED, THIS REPORT SHALL BE UPDATED. THIS REPORT IS IN REFERENCE TO UF/IMPORTER REPORT # (B)(6). 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 (B)(4). GYRUS ACMI REGISTRATION NUMBERS (B)(4). (B)(4).

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: "ONE HOUR INTO THIS TRANSURETHERAL RESECTION (TUR), THE ERROR CODE ALARMED ON THE OLYMPUS BIPOLAR MACHINE. THE SURGEON TRIED TROUBLESHOOTING, THEN TOOK THE SCOPE APART AND NOTICED THE LOOP HAD COME APART. THE RED PART FROM THE METAL LOOP. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HF RESECTION ELECTRODES RESECTION ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22306D 109W

    Patients

    Seq Age Sex Outcome Treatment
    1 AN OLYMPUS ELECTROSURGICAL UNIT WITH UNSPECIFIED| SERIAL AND MODEL NUMBERS. | AN OLYMPUS ELECTROSURGICAL UNIT WITH UNSPECIFIED| SERIAL AND MODEL NUMBERS.