BEUDAMED
    FDA Adverse Event Other Summary report: N

    5X100MM THREADED NON-SHIELDED TROCAR

    MDR report key: 879749 · Received July 10, 2007

    Report

    Report Number
    2027111-2007-00059
    Event Type
    Other
    Date Received
    July 10, 2007
    Date of Event
    June 13, 2007
    Report Date
    July 10, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: C0522 THE EVALUATION OF UNIT SHOWED THAT A PIECE OF DUCKBILL SEAL HAD BEEN TORN AWAY. THE MISSING PIECE WAS RETURNED WITH THE DEVICE. NO OTHER DAMAGE TO THE SEAL WAS APPARENT. CONCLUSION/CORRECTIVE ACTION: C0522 AFTER EVALUATING THE UNIT APPLIED'S ENGINEERING DEPARTMENT SUCCESSFULLY RECREATED THE FAILURE BY INSERTING AN ETHICON ACE HARMONIC SCALPEL THROUGH A 5MM TROCAR. DUE TO THE SHARP CORNER ON THE HARMONIC BLADE IT IS POSSIBLE TO "HOOK" THE DUCKBILL SEAL IF THE INSTRUMENT IS INSERTED INTO THE SEAL AT A LOW ANGLE (AWAY FROM THE AXIS OF THE TROCAR). THE TEST WAS REPEATED WITH THE ETHICON ENDOPATH 5MM TROCARS AND SIMILAR DAMAGE COULD BE CAUSED TO THE SEPTUM SEAL. TESTING OF APPLIED'S KII TROCAR AND ETHICON'S CELL TROCAR DID NOT PRODUCE AND FAILURES. AS STATED IN THE PRODUCT INFORMATION DATA SHEET, CARE SHOULD BE TAKEN WHEN INSERTING SHARP INSTRUMENTS TO AVOID DAMAGING THE TROCAR SEALS. IN CONCLUSION, APPLIED MEDICAL RECOMMENDS USING A 5MM KII OR UNIVERSAL SEAL WHEN USING INSTRUMENTS SUCH AS THE ETHICON ACE DUE TO THEIR INCORPORATION OF A SHIELD TO PROTECT AND REDUCE THE LIKELIHOOD OF DAMAGE CAUSED BY SHARP INSTRUMENTS. APPLIED MEDICAL WILL CONTINUE TO MONITOR CER (CUSTOMER EXPERIENCE REPORT) SYSTEM FOR DEVELOPING TRENDS; HOWEVER, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    "C0522 - DR. INSERTED HARMONIC SCALPEL INTO TROCAR. UPON ENTRY A BLACK PIECE OF RUBBER WAS HANGING FROM HARMONIC SCALPEL - PART OF THE SEAL FELL INTO PELVIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5X100MM THREADED NON-SHIELDED TROCAR TROCAR DRC APPLIED MEDICAL RESOURCES C0522 1038467

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other