BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIPORT5.5MM SHORT SECONDARY PORT

    MDR report key: 1821092 · Received August 27, 2010

    Report

    Report Number
    2647580-2010-00733
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 30, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: PLASTIC VALVE BROKE, FALLING INTO THE PT CAVITY. PIECE WAS REMOVED. DOCTOR WAS ABLE TO CONTINUE THE CASE. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIPORT5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0D0119

    Patients

    Seq Age Sex Outcome Treatment
    1