BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TROCAR

    MDR report key: 28934 · Received July 7, 1995

    Report

    Report Number
    28934
    Event Type
    Injury
    Date Received
    July 7, 1995
    Date of Event
    February 23, 1995
    Report Date
    February 28, 1995
    Manufacturer
    HAKLEY-ROBERTS CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS INFLATING THE PREPERITONEAL DISTENTION BALLOON, THE BALLOON BURST INTO PIECES. PART OF THE BALLOON CAME OUT WITH THE SET, & 1 PIECE OF BALLOON WAS RETRIEVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM TROCAR TROCAR GCJ HAKLEY-ROBERTS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention