BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 1900540 · Received November 10, 2010

    Report

    Report Number
    2647580-2010-00891
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Adverse Event
    Yes
    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: LAPAROSCOPIC NEPHRECTOMY. PT GENDER: UNK. ACCORDING TO THE REPORTER: DURING THE CASE AFTER PUMPING THE BALLOON 20 TIMES, THE BALLOON WAS BURST. THE PIECE MIGHT REMAIN IN PT'S CAVITY. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED. NO PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER PREPERITONEAL DIST BALLOON DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0E0379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other