BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 677319 · Received February 8, 2006

    Report

    Report Number
    2020550-2006-00006
    Event Type
    Other
    Date Received
    February 8, 2006
    Date of Event
    January 5, 2006
    Report Date
    February 7, 2006
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FEO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A KIDNEY STONE REMOVAL PROCEDURE ON A FEMALE. AT THE END OF THE PROCEDURE AFTER BREAKING UP THE KIDNEY STONES AND SUCTIONING THEM OUT, HE WAS USING A FLUOROSCOPY MACHINE TO SEE IF THERE WERE ANY FRAGMENTS LEFT IN THE PATIENT WHEN HE SPOTTED AN OBJECT IN THE X-RAY. HE REALIZED THIS WAS NOT A STONE FRAGMENT BUT MOST LIKELY THE TIP OF THE 27093LL. HE REMOVED THIS INSTRUMENT AND CONFIRMED THAT THE OSCILLATING TIP HAD COME OFF. HE SPENT 30-40 MINUTES REMOVING TIP WITH A GRASPER. PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT ON PATIENT. PATIENT CONDITION POST OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ULTRASONIC PROBE FEO KARL STORZ GMBH & CO. KG 27093LL CF

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other