BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 2061389 · Received March 17, 2011

    Report

    Report Number
    2647580-2011-00186
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 22, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TEP. ACCORDING TO THE REPORTER: GRAY SEAL BROKE. USED OTHER DEVICE. NO BLEEDING. NOTHING FELL INTO THE PATIENT CAVITY. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PATIENT INFO AVAILABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0K0602

    Patients

    Seq Age Sex Outcome Treatment
    1