BEUDAMED
    FDA Adverse Event Summary report: N

    SURGIWAND II 5MM W/CAUT/L-HOOK/TUBE/GFS

    MDR report key: 4190119 · Received October 21, 2014

    Report

    Report Number
    2647580-2014-00766
    Date Received
    October 21, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GEI
    PMA / PMN Number
    K961771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING USE ON PATIENT, THE TIP OF THE SHAFT MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668588 SURGIWAND II 5MM W/CAUT/L-HOOK/TUBE/GFS SINGLE USE LAPAROSCOPIC HAND INSTRUMENT GEI COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1