BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    +IO- 5.5MM/65MM GUARDED TROCR/CANN W/GAS

    MDR report key: 1933440 · Received December 3, 2010

    Report

    Report Number
    2647580-2010-00931
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 2, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. PT GENDER: UNK. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT DURING INSERTION OF THE OBTURATOR INTO THE CANNULA OF THE TROCAR, IT APPEARED THAT THE OBTURATOR BLADE CUT PART OF THE SEAL AND THEN ENDS UP ON THE END OF THE BLADE AS THE SURGEON IS ABOUT TO APPLY IT TO TISSUE. THE SURGEON IS CONCERNED THAT FOREIGN BODIES COULD END UP IN THE PT. THE SAMPLE IS BEING SENT FOR EVALUATION. NO FOREIGN BODY FELL INTO THE PT IN THIS INSTANCE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +IO- 5.5MM/65MM GUARDED TROCR/CANN W/GAS DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0G0763

    Patients

    Seq Age Sex Outcome Treatment
    1