BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36MM - 15MM ACTIV

    MDR report key: 1210084 · Received October 22, 2008

    Report

    Report Number
    3005075853-2008-02510
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP HEMICOLECTOMY PROCEDURE, THE DEVICE STOPPED WORKING. THE STAFF FOLLOWED TROUBLESHOOTING STEPS. BUT THEY COULD NOT FIX THE PROBLEM, SO THEY OPENED A NEW DEVICE. THE 2ND DEVICE WORKED FINE. HOWEVER, AT THE END OF THE CASE, THE STAFF REALIZED THAT THE ACTIVE BLADE ON THE FIRST BLADE HAD BROKEN OFF. THE STAFF COULD NOT FIND THE BROKEN PART OF THE ACTIVE BLADE. IT COULD POTENTIALLY BE INSIDE THE PATIENT. THE PATIENT WAS X-RAYED AND THE BROKEN BLADE DID NOT SHOW UP ON THE X-RAY. THEREFORE, THE PATIENT WAS NOT TAKEN BACK TO THE OPERATING THEATRE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36MM - 15MM ACTIV GEI ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE