BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERPRT PLUS V2 5MM-12MM TRC

    MDR report key: 1981456 · Received January 11, 2011

    Report

    Report Number
    2647580-2011-00027
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    HET
    PMA / PMN Number
    K952977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GYNECOLOGY. ACCORDING TO THE REPORTER: THE CLIENT REPORTS THAT AT THE END OF THE OPERATION, THE TROCAR SLEEVE BROKE INSIDE THE PATIENT ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PART. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERPRT PLUS V2 5MM-12MM TRC DISPOSABLE SURGICAL ACCESS DEVICE HET USSC PUERTO RICO P0K0303

    Patients

    Seq Age Sex Outcome Treatment
    1