BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAKAHASHI RONG 5", 4X10 MM

    MDR report key: 490041 · Received September 9, 2003

    Report

    Report Number
    9680515-2003-00003
    Event Type
    Other
    Date Received
    September 9, 2003
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    ---
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR, THE SURGEON WAS USING A RONGEUR ON VENTRICLE ABOVE AORTA AND THE INSTRUMENT BROKE AND THEY WERE UNABLE TO DETERMINE IF A PIECE WAS MISSING. THERE WAS NO PATIENT INJURY WHATSOEVER. THE INSTRUMENT CANNOT BE EVALAUTED DUE TO THE FACT THAT THE HOSPTIAL SENT IT TO ANOTHER COMPANY FOR REPAIR. ACCORDING TO THE DISTRIBUTOR IT COULD NOT BE EVEN TRACED. COMPANY CAN THOUGH CONFIRM, THAT THIS TYPE OF INSTRUMENT WAS ALWAYS PRODUCED WITH THE CORRECT STEEL AND ACCORDING TO THE RESPECTIVE SPECIFICATIONS. AFTER CHECKING THE TREND ANALYSIS RECORDS COMPANY WOULD LIKE TO STATE THAT AS OF TODAY, COMPANY HAS NEVER RECEIVED BACK A BROKEN TAKAHASHI RONGEUR FROM ANY CUSTOMERS/DISTRIBUTORS NOR IS COMPANY AWARE OF ANY SUCH INCIDENTS. IN ADDITION COMPANY WOULD LIKE TO STATE THAT COMPANY HAS BEEN MFG THIS INSTRUMENT FOR MORE THAN 20 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAKAHASHI RONG 5", 4X10 MM TAKAHASHI RONG 5", 4X10MM --- TONTARRA MEDIZINTECHNIK GMBH * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1