BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM SILS PORT

    MDR report key: 2945936 · Received January 7, 2013

    Report

    Report Number
    1219930-2013-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K093372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: A 3 CM OF INCISION WAS MADE UNDER UMBILICUS, AND THE SILS PORT WAS PLACED PREPERITONEAL CAVITY. PROCEDURE WAS PERFORMED WITH FORCEPS AND HARMONIC (ULTRASOUND SYSTEM). AFTER ABOUT 15-MINUTES USE, THE SURGEON FOUND FOREIGN MATERIAL IN THE CAVITY AND RETRIEVED IT. HE NOTICED A PART OF THE SILS PORT SEAL WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT REPLACEMENT. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7781 12MM SILS PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SURGICAL N1L0101KX

    Patients

    Seq Age Sex Outcome Treatment
    1