BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP PLUS 12MM CANN/DILT W/RADEXPSL

    MDR report key: 3062552 · Received March 18, 2013

    Report

    Report Number
    2647580-2013-00144
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 21, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC R
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    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: THORACOSCOPY. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT AT THE END OF THE PROCEDURE, THE TROCAR WAS REMOVED FROM THE PT AND IT WAS NOTICED THAT A PIECE OF PLASTIC WAS MISSING, WHICH REMAINED IN THE EXPANDABLE SLEEVE. WHEN IT WAS REMOVED FROM THE PT, A PLASTIC CHIP RETURNED WITH THE INSTRUMENT. ANOTHER DEVICE WAS USED WITHOUT FURTHER CONSEQUENCE. NO PT INJURY OR ILL-EFFECTS. NO MEDICAL INTERVENTION REQUIRED. NO UNANTICIPATED TISSUE LOSS, TISSUE DAME OR BLEEDING. NO EXTENSION TO SURGICAL TIME REQUIRED. NOTHING FELL IN THE SURGICAL CAVITY. PT CURRENT STATUS REPORTED AS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112669 VERSASTEP PLUS 12MM CANN/DILT W/RADEXPSL DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC R P2D0557X

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR