BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1377587 · Received March 5, 2009

    Report

    Report Number
    2647580-2009-00083
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    January 28, 2009
    Report Date
    January 30, 2009
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGIC. ACCORDING TO THE REPORTER: WHILE INSERTING A SCOPE INTO THE TROCAR, A FOREIGN MATERIAL WAS FOUND INSIDE OF THE TROCAR SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER. NOTHING FELL INTO THE CAVITY. NO PT INJURY. EXTENDED OPERATING TIME: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1