BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEP

    MDR report key: 7868238 · Received September 12, 2018

    Report

    Report Number
    7868238
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    June 25, 2018
    Report Date
    August 3, 2018
    Manufacturer
    COVIDIEN LP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A COVIDIEN STEP PORT (STEP AUTO SUTURE DILATOR AND CANNULA WITH RADIALLY EXPANDABLE SLEEVE, 5MM, REF #S100705, LOT #P8B0861X) WAS USED IN THIS CASE FOR A THORACOSCOPY. UPON INSERTING THE CAMERA THROUGH THE PORT, DEBRIS WAS SEEN INSIDE THE THORACIC CAVITY. PIECES OF DEBRIS WERE SUCCESSFULLY REMOVED, BUT AS THE CAMERA OR OTHER INSTRUMENTS CONTINUED TO BE INSERTED THROUGH THE PORT, MORE DEBRIS WAS NOTED. IT WAS DECIDED THAT THE DEBRIS WAS COMING FROM THE PORT SO IT WAS REMOVED FROM THE PATIENT. ANY DEBRIS VISUALIZED DURING THE THORACOSCOPY WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709105 STEP LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ COVIDIEN LP S100705 P8B0861X

    Patients

    Seq Age Sex Outcome Treatment
    1 5110 DA