BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1014040 · Received March 14, 2008

    Report

    Report Number
    2647580-2008-00140
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Report Date
    February 25, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP APPENDECTOMY PATIENT GENDER: UNKNOWN ACCORDING TO THE REPORTED: THE BALLOON BROKE AND THE TROCAR CAME OFF THE ABDOMINAL WALL DURING SURGERY. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. THE OPERATING TIME WAS EXTENDED BY 5 MINUTES. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK