BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO RETRACT II 10MM INSTRUMENT

    MDR report key: 3021632 · Received March 15, 2013

    Report

    Report Number
    2647580-2013-00147
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC P
    Product Code
    GCJ
    PMA / PMN Number
    K920068
    Adverse Event
    Yes
    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: LAPAROSCOPIC NEPHRECTOMY. ACCORDING TO THE REPORTER: THE PART ON THE DISTAL END OF SHAFT WAS BROKEN UP. BROKEN PIECE FELL INTO CAVITY AND THE BROKEN PIECE COULD NOT BE RETRIEVED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110819 ENDO RETRACT II 10MM INSTRUMENT SINGLE USE SPECIMEN RETRIEVAL PRODU GCJ COVIDIEN, FORMERLY USSC P P2F0313X

    Patients

    Seq Age Sex Outcome Treatment
    1