BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO RETRACT II 10MM INSTRUMENT

    MDR report key: 2021974 · Received March 8, 2011

    Report

    Report Number
    2647580-2011-00154
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    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 TYPE: PROSTATECTOMY. ACCORDING TO THE REPORTER: IN USE, THE PART WAS BROKEN AND THE BLACK PLASTIC PART FELL INTO THE PT CAVITY. THE PIECE WAS RETRIEVED. USED OTHER DEVICE. NO BLEEDING. NO TISSUE DAMAGED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO RETRACT II 10MM INSTRUMENT SINGLE USE LAPAROSCOPIC HAND INSTRUMENT GCJ USSC PUERTO RICO P0M1056

    Patients

    Seq Age Sex Outcome Treatment
    1