BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BL VP V2 5MM STD W/FX

    MDR report key: 3100042 · Received April 29, 2013

    Report

    Report Number
    1219930-2013-00297
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GCJ
    PMA / PMN Number
    K112349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TUBAL LIGATION. ACCORDING TO THE RPTR: WHEN A 5MM TROCAR FIRST ENTERED INTO THE ABDOMEN THROUGH UMBILICUS, THE OBTURATOR WAS REMOVED IN ORDER TO PUT THE 5MM SCOPE IN. WHILE PULLING OUT THE OBTURATOR, THE SURGEON STRUGGLED TO REMOVE IT. THIS IS WHEN THE SEAL WAS DISLODGED AND SEATED INCORRECTLY. THEREFORE, IT WAS IN THE WAY OF A SMOOTH EXIT OF THE OBTURATOR. THE SEAL DID NOT DISLODGE INTO THE PT'S CAVITY. THERE WAS NO INJURY TO THE PT OR THE USER. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 250CC. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184211 OPT BL VP V2 5MM STD W/FX DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SUR N3A0609X

    Patients

    Seq Age Sex Outcome Treatment
    1