BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO RETRACT II 10MM INSTRUMENT

    MDR report key: 1933289 · Received December 15, 2010

    Report

    Report Number
    2647580-2010-00964
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K920068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: IN USE FOR TWO HOURS AND HALF, TWO BLACK PARTS WERE FOUND BROKEN OFF. THE PARTS SEEMED TO BE FROM THE TIP OF THE DEVICE. THE PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO RETRACT II 10MM INSTRUMENT DISPOSABLE SURGICAL ACCESSORY GCJ USSC PUERTO RICO P0J0557

    Patients

    Seq Age Sex Outcome Treatment
    1