BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1993569 · Received January 21, 2011

    Report

    Report Number
    2647580-2011-00050
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 23, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K984011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: DURING USE, THE PLASTIC REDUCING SLEEVE IN THE TROCAR BECAME DETACHED AND WAS PUSHED DOWN TOWARD THE END OF THE INSTRUMENT AND INTO THE CAVITY. THE REDUCING SLEEVE WAS RETRIEVED WITH AN ENDO INSTRUMENT AND, ALONG WITH THE TROCAR, REMOVED FROM USE. THERE WAS NO ADD'L BLEEDING, NO TISSUE DAMAGE AND NEITHER THE OPERATIVE TIME NOR THE INCISION SIZE WERE EXTENDED. PT IS FINE. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0H0090

    Patients

    Seq Age Sex Outcome Treatment
    1