BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM LOOP ELECTRODE FOR 30 DEGREE TELESCOPES

    MDR report key: 2237270 · Received July 28, 2011

    Report

    Report Number
    9610773-2011-00017
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT AFTER MAKING LESS THAN 5 PASSES, A TINY PIECE ON THE LEFT-ARM SIDE AND UP TOWARD THE INTERIOR LOOP ON THE INSULATION WIRE OF THE SUBJECT DEVICE WAS NOTED MISSING, AND IT WAS DETECTED TOWARD THE VERY END OF THE PROCEDURE. THE MISSING PIECE WAS REPORTEDLY NOT RETRIEVED BUT RATHER LEFT INSIDE THE PT FOR IT TO BE EXCRETED NATURALLY. THE SUBJECT DEVICE OF THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT CONFIRM THE USER'S REPORT. THE BLUE, YELLOW, WHITE INSULATION AND THE LOOP WIRE WERE INTACT. THE SUBJECT DEVICE WAS EVALUATED WITH AN ELECTROSURGICAL UNIT WITHOUT ANY PROBLEMS FOUND, AND THE OUTPUT WAS NORMAL. THERE WAS EVIDENCE OF SALINE SOLUTION RESIDUE ON THE SURFACE OF THE YELLOW INSULATION. THE SUBJECT DEVICE WAS FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER EVAL. OLYMPUS AMERICA INC IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORP. (B)(4). THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A BLADDER TUMOR PROCEDURE, A PIECE OF THE INSULATION WIRE FROM THE SUBJECT DEVICE REPORTEDLY FELL OFF IN THE PT'S BLADDER. THE PROCEDURE WAS REPORTEDLY COMPLETED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIUM LOOP ELECTRODE FOR 30 DEGREE TELESCOPES ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22606D 101W

    Patients

    Seq Age Sex Outcome Treatment
    1 PK SUPERPULSE GENERATOR WITH SERIAL NUMBER (B)(4)| PK SUPERPULSE GENERATOR WITH SERIAL NUMBER (B)(4)