BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR, 80MM ANG TRIANGULAR

    MDR report key: 493623 · Received November 3, 2003

    Report

    Report Number
    1038548-2003-00005
    Event Type
    Malfunction
    Date Received
    November 3, 2003
    Report Date
    November 3, 2003
    Manufacturer
    SNOWDEN PENCER, INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RETRACTABLE LAPAROSCOPIC (TRIANGULAR) LIVER RETRACTOR WAS BEING USED DURING A LAPAROSCOPIC NISSEN PROCEDURE. A WIRE APPARENTLY BROKE AT THE CONNECTION OF THE FLEXIBLE PART WITH THE RIGID PART OF THE INSTRUMENT AND PROTRUDED SHARPLY ABOUT 1/2 INCH RESULTING IN A 3CM SUPERFICIAL LACERATION TO THE LEFT LOBE OF THE PATIENT'S LIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETRACTOR, 80MM ANG TRIANGULAR * GAD SNOWDEN PENCER, INC. 89-6112 7040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other