BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 MM SHORT SECONDARY PORT

    MDR report key: 3896731 · Received May 20, 2014

    Report

    Report Number
    9612501-2014-00154
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    COVIDIEN
    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: HYSTERECTOMY. ACCORDING TO THE REPORTER: IT WAS REPORTED TO ME THAT WHILST USING A PEDIPORT TROCAR, A SMALL PIECE OF THE TROCAR FELL INTO THE PT. THE DR NOTICED IT FALL AND RETRIEVED IT FROM THE PT'S ABDOMEN. THIS IS ALL THE INFO PROVIDED. SMALL SPECIMEN THAT FELL OFF WAS RETURNED AND WILL BE SENT WITH THIS REPORT, BUT NO TROCAR WAS RETURNED AND NO LOT NUMBERS RECORDED. CORRECTIVE ACTION TAKEN RELEVANT TO THE CARE OF THE PT: SPECIMEN RETRIEVED. PT OUTCOME: NO HARM OR INJURY. NUMBER PTS INVOLVED: 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299252 5.5 MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1