BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF RESECTION ELECTRODE - LOOP

    MDR report key: 4173536 · Received October 10, 2014

    Report

    Report Number
    2951238-2014-00445
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    PMA / PMN Number
    K903323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT IN THE MIDDLE OF A TRANSURETHRAL RESECTION OF THE BLADDER TUMOR (TURBT) PROCEDURE, THE RESECTION LOOP BROKE OFF AND FELL INSIDE THE PATIENT'S BLADDER. A VISUAL EXAMINATION OF THE BLADDER WAS PERFORMED AFTER IRRIGATION BUT THE DEVICE FRAGMENT WAS NOT FOUND. THE PROCEDURE WAS DELAYED FOR AN UNSPECIFIED AMOUNT OF TIME, BUT THERE WAS NO PATIENT HARM REPORTED. IT WAS ALSO REPORTED THAT A FLUOROSCOPY, ANTERIOR POSTERIOR(AP) AND LATERAL FLAT PLATE X-RAYS WERE PERFORMED, BUT NO DEVICE FRAGMENT WERE FOUND. A SECOND DEVICE WAS USED IN THE PROCEDURE, AND THE ELECTRODE LOOP WAS BROKEN. IT WAS REPORTED THAT NO DEVICE FRAGMENT FELL INSIDE THE PATIENT. A THIRD DEVICE WAS USED AND THE INTENDED PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642649 HF RESECTION ELECTRODE - LOOP RESECTION ELECTRODE KNS OLYMPUS WINTER & IBE GMBH WA22302D 12180P01L002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other MODEL: WA22521C SERIAL#: (B)(4), MFR REPORT#:| 2951238-2014-00449.