BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEP 10MM

    MDR report key: 35367 · Received June 28, 1996

    Report

    Report Number
    35367
    Event Type
    Injury
    Date Received
    June 28, 1996
    Date of Event
    March 20, 1996
    Report Date
    April 15, 1996
    Manufacturer
    INNERDYNE INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING A 10MM TROCAR AFTER INSERTION. IT WAS NOTED THAT THE PLASTIC SHEATH WAS SPLIT BUT INTACT. AFTER THE PROCEDURE WAS COMPLETE AND DURING REMOVAL OF TOCAR, THE PART THAT WAS SPLIT, BROKE OFF. SURGEON HAD TO REMOVE THE PIECES FROM THE PT; ALL PIECES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP 10MM TROCAR GCJ INNERDYNE INC. STEP 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention