BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPORT 10MM

    MDR report key: 110 · Received February 19, 1992

    Report

    Report Number
    110
    Event Type
    Injury
    Date Received
    February 19, 1992
    Date of Event
    January 23, 1992
    Report Date
    February 4, 1992
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    FBQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING LAPAROSCOPY PROCEDURE WHEN SIGNIFICANT AMOUNT OF BLEEDING WAS ENCOUNTERED ON THE LEFT SIDE OF RETROPERITONEUM. 12MM TROCAR PLACED IN UMBULICUS. 5MM PLACED UNDER DIRECT VISUALIZATION. 10MM TROCAR PLACED ON LEFT SIDE WALL. TROCAR PASSED THROUGH MESENTERIC SMALL BOWEL AND LACERATED LATERAL SIDE COMMON ILIAC ARTERY/VEIN.VASCULAR SURGEON CALLED, LEFT ILIAC VEIN REPAIRED. GORE-TEX GRAFT TO ARTERT. PATIENT DISCHARGED 9 DAYS LATER IN STABLE CONDITIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPORT 10MM DISPOSABLE SURGICAL TROCAR FBQ UNITED STATES SURGICAL CORPORATION P1G143

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention