BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3034898 · Received March 26, 2013

    Report

    Report Number
    9610617-2013-00011
    Event Type
    Other
    Date Received
    March 26, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 26, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FCL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DAMAGE NOTED ON THE ELECTRODE. IT WAS HIPOT TESTED AND PASSED.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING TURBT PROCEDURE WHEN BIPOLAR CUTTING LOOP CUT THROUGH THE BLADDER INTO THE FAT SECONDARY LAYER. THE DOCTOR COMPLETED THE CASE WITH ANOTHER ELECTRODE. PT TREATED WITH FOLEY CATHETER DRAINAGE FOR TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123911 KARL STORZ BIPOLAR CUTTING LOOP FCL KARL STORZ GMBH & CO. KG 27040GPV VX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other