BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1

    MDR report key: 3131047 · Received May 21, 2013

    Report

    Report Number
    2647580-2013-00265
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    August 9, 2012
    Report Date
    April 26, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: UPON COMPLETING THE PROCEDURE AND REMOVING THE TROCAR VERSASTEP 12MM, IT WAS NOTICED THAT A PIECE OF THE TROCAR WAS STILL IN THE PATIENT. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO INJURY TO THE PATIENT OR THE USER. THE PATIENT REFUSED TO HAVE THE BROKEN PIECE REMOVED INITIALLY. PER RISK MANAGEMENT DEPARTMENT AT (B)(6), THE PATIENT HAS SINCE HAD THE BROKEN PIECE REMOVED AT ANOTHER INSTITUTION. THE TROCAR MINUS THE FRAGMENT THAT WAS LEFT IN THE PATIENT WILL BE RETURNED TO QUALITY ASSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225703 VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1 DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P1MO906

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other