BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRISTAR TROCAR

    MDR report key: 35152 · Received August 9, 1996

    Report

    Report Number
    MW1009679
    Event Type
    Other
    Date Received
    August 9, 1996
    Date of Event
    May 29, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 5/31/96 A SURGEON WAS IN THE INITIAL PHASE OF PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. SOME DIFFICULTY WAS ENCOUNTERED WITH INSERTING THE TROCAR BUT THE FUNCTION OF THE INSTRUMENT AT THE TIME WAS NOT IN QUESTION. UNFORTUNATELY WHEN THE ABDOMEN WAS ENTERED IT WAS FOUND THAT THERE WAS A LACERATION OF THE VENA CAVA. THIS WAS REPAIRED QUICKLY. POST OPERATIVELY THE PT DEVELOPED A DVT OF THE LOWER EXTREMITY AND A HEMATOMA THAT RESULTED IN A PROLONGED STAY. EXTENSIVE PEER REVIEW WAS DONE WITHIN 1 WEEK OF THE INCIDENT AND IT WAS FELT THAT THE TECHNIQUE USED BY THE MD WAS WELL WITHIN THE STANDARD PARAMETERS. AT THAT TIME A QUESTION WAS RAISED REGARDING THE TROCAR USED AND IF THERE COULD HAVE BEEN AN EQUIPMENT MALFUNCTION. THE SURGEON AND THE PEER REVIEWERS DID NOT THINK SO, HOWEVER, AT A GENERAL SURGERY MEETING 7/18/96 (SECOND REVIEW) THE QUESTION AGAIN SURFACED AND THE POSSIBILITY OF MALFUNCTION OF THE TROCAR WAS AGAIN RAISED. RPTR IS QUITE CONFIDENT THAT THIS WAS NOT USER ERROR AS THIS MD HAS PERFORMED AT LEAST 400 LAP CHOLECYSTECTOMIES IN THE PAST AND PEER REVIEW ENDORSED HIS TECHNIQUE. FACILITY HAS RECENTLY QUESTIONED OTHER STAPLING PRODUCTS AND HAS IN FACT REQUESTED INFO THROUGH THE "FREEDOM OF INFO ACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRISTAR TROCAR LAPAROSCOPIC TROCAR GCJ ETHICON ENDO-SURGERY, INC. 511S

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other