BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRPT PLUS RPF 10MM-15MM TRC W/ 100MM SLV

    MDR report key: 2133289 · Received May 11, 2011

    Report

    Report Number
    2647580-2011-00326
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 18, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE SURGEON UTILIZED A UNDERSIZED 12MM OBTURATOR FROM ANOTHER PORT TO INSERT THE 15MM TROCAR WHEN THE CANNULA CRACKED AT THE BOTTOM EDGE. HE DID NOT INITIALLY WANTED TO USE THE INCLUDED 15MM BLADED OBTURATOR, WHICH MIGHT CONTRIBUTED TO THE NOTED DAMAGED. NO PIECES FELL INTO THE CAVITY. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VRPT PLUS RPF 10MM-15MM TRC W/ 100MM SLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P7B0695

    Patients

    Seq Age Sex Outcome Treatment
    1