BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GPASP 5MM W/SPIN LOCK

    MDR report key: 1970530 · Received January 19, 2011

    Report

    Report Number
    2647580-2011-00040
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 26, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GET
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING USE, THE BLACK SHAFT PART WAS BROKEN AND FELL INTO THE PT'S CAVITY. THE DEVICE WAS ROTICULATED WHEN THE INCIDENT OCCURRED. THE FALLEN PIECE WAS RETRIEVED FROM THE CAVITY, BUT THE DEVICE COULD NOT BE REMOVED FROM TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO GPASP 5MM W/SPIN LOCK DISPOSABLE SURGICAL DEVICE GET USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1