BEUDAMED
    FDA Adverse Event Death Summary report: N

    11MM, DISPOSABLE TROCAR W/SHIELDED OBTURATOR

    MDR report key: 832014 · Received March 27, 2007

    Report

    Report Number
    2027111-2007-00024
    Event Type
    Death
    Date Received
    March 27, 2007
    Date of Event
    March 6, 2007
    Report Date
    March 27, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE UNITS ARE IN ORIGINAL UNOPENED PACKAGE. THE OBTURATORS AND SEAL ASSEMBLIES WERE TESTED AND PASSED TEST CRITERIA. TESTING OF OBTURATOR ASSEMBLY-EACH UNIT WAS TESTED WITH ITS TROCAR AND WAS INSERTED INTO 1 INCH THICK FOAM MCMASTER P/N 8647K291. EACH OBTURATOR ASSEMBLY PENETRATED THROUGH THE FOAM AND THE GUARD IS LOCKED AND CANNOT RE-EXPOSE THE BLADE WITHOUT REARMING THE OBTURATOR. EACH UNIT WAS CYCLED TEN TIMES AND PASSED ALL TEN CYCLES. TESTING OF SEAL ASSEMBLY-EACH SEAL ASSEMBLY WAS TESTED AT 6.5", 9.0" AND 16.0" OF H2O WITH A 10MM SCOPE AND ALL SEAL ASSEMBLIES PASSED AT THE LEAKAGE TEST.

    Description of Event or Problem · 1

    "DURING A LAPAROSCOPIE CHOLECYSTECTOMIE (OPEN LAPAROSCOPIE) AFTER THE INTRODUCTION OF A TROCAR, WITHOUT WRONG MOVEMENT AND UNDER CONTROL OF THE SIGHT (SMALL REBOUND) FOLLOWING THE SMALL REBOUND, THERE WAS SOME BLOOD ON THE EPIPLOON AND A FALL OF THE PNEUMOPERITONEUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11MM, DISPOSABLE TROCAR W/SHIELDED OBTURATOR DISPOSABLE TROCAR HET APPLIED MEDICAL RESOURCES C0726 1025057

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death