BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSPRT RPF 5MM - 10MM TCR W/100MM

    MDR report key: 4093134 · Received September 10, 2014

    Report

    Report Number
    9612501-2014-00321
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Report Date
    August 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K954108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE BLADE OF THE DEVICE DID NOT RETRACT IN THE SLEEVE ONCE THE TROCAR WAS IN THE ABDOMINAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559650 VERSPRT RPF 5MM - 10MM TCR W/100MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR