BEUDAMED
    FDA Adverse Event Other Summary report: N

    11X10MM THRD SHIELDED TROCAR W/UNIVERSAL SEAL

    MDR report key: 1220577 · Received October 30, 2008

    Report

    Report Number
    2027111-2008-00060
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 31, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE ABSENCE OF THIS SUBJECT DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE AND FAILURE MODE. WE COULD NOT REVIEW THE DEVICE HISTORY RECORD OF THIS DEVICE DUE TO THE LOT NUMBER NOT BEING PROVIDED. AS A RESULT, WE ARE CONCLUDING OUR INVESTIGATION AND CLOSING THIS INCIDENT FILE. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "GYN SURGEON FULLY INSUFFLATED THE ABDOMEN WITH A VERESS NEEDLE. HE THEN ENTERED THE ABDOMEN WITH AN 11MM BLADED TROCAR AND PERFORATED THE VENA CAVA. A GENERAL AND VASCULAR SURGEON WERE CALLED IN AND COMPLETED THE NECESSARY REPAIRS. THE PT WAS MOVED TO THE ICU AND THEN LATER DISCHARGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11X10MM THRD SHIELDED TROCAR W/UNIVERSAL SEAL NONE GCJ APPLIED MEDICAL RESOURCES C0658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention