BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO RETRACT II 10MM INSTRUMENT

    MDR report key: 2133661 · Received June 8, 2011

    Report

    Report Number
    2647580-2011-00384
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K920068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: THE DEVICE WAS USED TO RETRACT THE KIDNEY. AT THE END OF THE CASE THE SURGEON ATTEMPTED TO REMOVE THE INSTRUMENT FROM THE TROCAR, BUT FOUND THAT IT WAS DIFFICULT TO REMOVE. ON FURTHER INSPECTION HE FOUND THAT THE INSTRUMENT WAS ARTICULATED, WHICH HE FOUND SURPRISING AS HE DOES NOT USE THE ARTICULATION FEATURE ON THIS INSTRUMENT. HE WAS ABLE TO STRAIGHTEN THE INSTRUMENT AND REMOVE IT FROM THE TROCAR, BUT THEN DISCOVERED THAT THE 2 BLACK PLASTIC SEMI CIRCLES WHICH ARE ATTACHED AT THE POINT OF ARTICULATION WERE NO LONGER ATTACHED. HE THEN SPENT SOME TIME LOOKING FOR THE PLASTIC PIECES INSIDE THE PT AND FOUND 3 FRAGMENTS OF PLASTIC. THE SURGEON BELIEVES THAT A FURTHER PIECE OF PLASTIC MAY HAVE BEEN LEFT INSIDE THE PT, BUT ALSO STATED THAT IT MAY HAVE BEEN REMOVED ALONG WITH THE SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO RETRACT II 10MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRU GCJ USSC PUERTO RICO POM1126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other