BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 796991 · Received October 17, 2006

    Report

    Report Number
    2020550-2006-00062
    Event Type
    Other
    Date Received
    October 17, 2006
    Date of Event
    September 15, 2006
    Report Date
    October 13, 2006
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A URETEROSCOPY LITHOTRIPSY, DR HAD FRAGMENTED HALF A STONE LOCATED IN THE LOWER POLE AND REMOVED THAT FRAGMENT AND WAS IN THE PROCESS OF FRAGMENTING THE OTHER PART OF THE STONE WHEN THE LASER PROBE INSIDE THE FLEXIBLE SCOPE CRACKED AND BURNED A HOLE IN THE FLEXIBLE SCOPE AT THE FLEXION POINT. DR ABORTED CASE AT THAT TIME DUE TO THE FACT THAT THEY DID NO HAVE A BACKUP SCOPE AND WILL RESCHEDULE IT AT A LATER DATE. THERE WAS AN 8MM (1.5CM WHOLE) PIECE LEFT THAT STILL HAS TO BE FRAGMENTED AND RETRIEVED. SHE STATED THERE WAS NO ADVERSE EFFECT ON PT; PATIENT CONDITION POST-OP WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ FLEXIBLE URETEROSCOPE FGB KARL STORZ ENDOVISION 11278AU1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other