BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIPORT 5.5MM SHORT SECONDARY PORT

    MDR report key: 1060952 · Received June 13, 2008

    Report

    Report Number
    2647580-2008-00345
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 23, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    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: DURING SURGERY, WHILE USING THE DEVICE A PIECE OF THE SEAL FELL INTO THE PATIENT CAVITY, HOWEVER, IT WAS RETRIEVED. SINCE THE FORCEPS WERE INSERTED INTO THE PORT, IT DID NOT ALLOW THE AIR TO LEAK OUT AND THE PROCEDURE WAS CONTINUED WITH THE SAME DEVICE. THERE WAS NO TISSUE DAMAGE NOR BLEEDING. THE OPERATING TIME WAS NOT EXTENDED AS A RESULT. NO PATIENT INJURY WAS REPORTED. PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIPORT 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS

    Patients

    Seq Age Sex Outcome Treatment
    1