BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIPORT 5.5MM SHORT SECONDARY PORT

    MDR report key: 1250828 · Received November 25, 2008

    Report

    Report Number
    2647580-2008-00658
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    October 29, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 11/24/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. PT GENDER: UNK. ACCORDING TO THE RPTR: INNER SEAL ON THE DEVICE BROKE AND FELL OFF THE DEVICE. THE INSTRUMENT WAS NOT USED ON THE PROCEDURE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. 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.

    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 P8H0245

    Patients

    Seq Age Sex Outcome Treatment
    1