BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1

    MDR report key: 2823569 · Received October 8, 2012

    Report

    Report Number
    2647580-2012-00622
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 11, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: THE PHOTOGRAPH OF THE WIRE WAS EVALUATED BY ENGINEERS AND CONFIRMED TO NOT BE A COMPONENT OF EITHER DEVICE REPORTED BY THE USER.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY ACCORDING TO THE REPORTER: AS THE PT UNDERWENT A LAPAROTOMY, A FINE WIRE ABOUT 2 CM IN LENGTH WAS FOUND IN THE ABDOMINAL CAVITY AND RETRIEVED. ABOUT 10 YEARS AGO, THE PT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AT THE SAME HOSPITAL. VERSASTEP AND ENDO CATH GOLD COULD HAVE BEEN USED IN THE CASE. IT WAS SUSPECTED THE FOUND WIRE WAS PART OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1 DISPOSABLE SURGICAL ACCESSORY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDO CATH GOLD 10MM SPECIMEN POUCH INTL: 173050G,| K922123