BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1509331 · Received October 9, 2009

    Report

    Report Number
    9613347-2009-00033
    Event Type
    Other
    Date Received
    October 9, 2009
    Date of Event
    July 24, 2009
    Report Date
    October 7, 2009
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HEMATOMA IS A KNOWN SIDE EFFECT OF ESWL LITHOTRIPSY TREATMENT AND IS ADDRESSED IN OUR LABELING. AT FORTEC'S REQUEST, A COMPLIMENTARY SERVICE EVAL WAS PERFORMED ON THIS SYSTEM THE DAY PRIOR TO THE INCIDENT. SERVICE TECH FOUND A LOOSE CONNECTOR FOR THE INFLATION OF THE AIRBAGS AND RE-SECURED IT. SERVICE TECH REPORTED THAT THE COMPLETE SYSTEM WAS OPERATING PROPERLY AT THE CONCLUSION OF THE SERVICE VISIT. NO MALFUNCTION WAS NOTED OR REPORTED AT THE TIME OF THE PROCEDURE. THERE WERE 5 OTHER PTS THAT RECEIVED TREATMENT ON THE SAME DAY, AND NONE OF THEM REPORTED ANY DIFFICULTIES. UNIT HAS BEEN IN CONTINUOUS SERVICE SINCE THE EVENT. THERE IS NO PLAN TO SCHEDULE EVAL OF UNIT.

    Description of Event or Problem · 1

    ALLEGEDLY, POST AN ESWL LITHOTRIPSY PROCEDURE, PT WAS ADMITTED TO HOSPITAL FOR TREATMENT OF A HEMATOMA. AFTER OVERNIGHT STAY, PT WAS RELEASED AND CONDITION REPORTED TO BE GOOD. THIS EVENT WAS REPORTED BY FORTEC/OWNER-OPERATOR OF THE SLX-F2; THE EVENT OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ MODULITH SLX-F2 LQC STORZ MEDICAL AG SLX-F2

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other