BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 MM SHORT SECONDARY PORT

    MDR report key: 3821205 · Received April 29, 2014

    Report

    Report Number
    9612501-2014-00130
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: 4 PEDIPORTS LEAKED ON REMOVAL OF TROCAR. SOME PARTS OF SEAL BROKE OFF AND DROPPED INTO PATIENT AND WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256507 5.5 MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN J3J0164X

    Patients

    Seq Age Sex Outcome Treatment
    1