BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT

    MDR report key: 2024067 · Received March 11, 2011

    Report

    Report Number
    2647580-2011-00163
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Report Date
    February 21, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K963115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: A PIECE OF METAL WAS FOUND AND THEY THINK IT WAS FROM THE VISIPORT, IT DID CUT AND THEY COULD NOT CHECK IF THE WAS FROM THE VISIPORT. CURRENT PT STATUS IS GOOD. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0E0450

    Patients

    Seq Age Sex Outcome Treatment
    1