BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIPORT 5.5MM SHORT SECONDARY PORT

    MDR report key: 1833514 · Received September 8, 2010

    Report

    Report Number
    2647580-2010-00754
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE SEAL FROM THE PORT BROKE DURING THE CASE AND IT LEAKED THROUGHOUT CASE. 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 USSC PUERTO RICO P0C0911

    Patients

    Seq Age Sex Outcome Treatment
    1