BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADELESS VP 12MM ST W/ FIXATION

    MDR report key: 2870125 · Received December 4, 2012

    Report

    Report Number
    2647580-2012-00752
    Event Type
    Injury
    Date Received
    December 4, 2012
    Report Date
    November 6, 2012
    Manufacturer
    COVIDEN, FORMERLY USSC P
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: FOUND PIECES OF PLASTIC UP ON RETRACTION OF THE TROCAR. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 12MM ST W/ FIXATION SINGLE USE SPECIMEN RETRIEVAL PRODU GCJ COVIDEN, FORMERLY USSC P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other