BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATING HOOK WITH MONOPOLAR CAUTERY

    MDR report key: 2933378 · Received December 21, 2012

    Report

    Report Number
    1219930-2012-00998
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K091869
    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: THORACIC. ACCORDING TO THE REPORTER: SILS PORT WAS PLACED ABOVE THE XIPHOID PROCESS. IT WAS QUITE DIFFICULT TO SEE IN THE THORACIC CAVITY, AND WHILE STRIPPING OFF THE PLEURA, THE BLACK INSULATING COATING (ABOUT 3CM IN LENGTH) WAS PEELED OFF AND THE METAL PART WAS EXPOSED. THE PEELED COATING WAS FOUND AROUND THE SILS PORT AND WAS RETRIEVED. A NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTEND BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULATING HOOK WITH MONOPOLAR CAUTERY SINGLE USE LAPAROSCOPIC HAND INSTRUMENT GCJ COVIDIEN, FORMERLY US SURGICAL N2G0608UX

    Patients

    Seq Age Sex Outcome Treatment
    1