BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1082097 · Received July 25, 2008

    Report

    Report Number
    2647580-2008-00415
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 26, 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 CHOLE. ACCORDING TO THE REPORTER: BALLOON WAS NOT UNIFORMLY EXPANDED, HOWEVER, THE INSTRUMENT COULD BE USED PROPERLY. JUST BEFORE SURGEON TRIED TO REMOVE SPECIMEN, THE BALLOON BROKE. SURGEON THINKS THAT HE DID NOT DAMAGE IT WITH THE SURGICAL INSTRUMENT. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY. THE OPERATING TIME WAS NOT EXTENDED. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED. PT STATUS: OK. NO FURTHER PT INFO AVAILABLE.

    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