BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIANGULAR RETRACTOR, 80MM

    MDR report key: 81060 · Received April 4, 1997

    Report

    Report Number
    1038548-1997-00035
    Event Type
    Injury
    Date Received
    April 4, 1997
    Date of Event
    March 3, 1997
    Report Date
    April 2, 1997
    Manufacturer
    SNOWDEN PENCER DSP WORLDWIDE, INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ACTUATION CABLE IN THE INSTRUMENT ALLEGEDLY BROKE DURING USE IN A FUNDOPLICATOR PROCEDURE. THE SURGEON HAD TIGHTENED THE ACTUATION KNOB AND FELT A SNAP. AFTER THE SNAP THE RETRACTOR RELAXED AND WOULD NOT UNSCREW. THE INSTRUMENT THEN CAME APART IN THE ABDOMEN OF THE PT. NO OTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIANGULAR RETRACTOR, 80MM ENDOSCOPIC RETRACTOR GAD SNOWDEN PENCER DSP WORLDWIDE, INC. 89-6112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention