BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

    MDR report key: 1160579 · Received September 11, 2008

    Report

    Report Number
    3005075853-2008-01652
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 19, 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

    DATE SENT: 09/11/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DISPOSABLE DEVICES APPEARED TO MALFUNCTION DURING A SINGLE THYROIDECTOMY PROCEDURE. TWO DEVICES WERE ATTACHED TO THE GENERATOR AND TESTED. PART WAY THROUGH THE INITIAL TEST, THE TESTING NOISE STOPPED, AND THE TESTING CYCLE COULD NOT BE COMPLETED WITH BOTH DEVICES. ANOTHER DEVICE WAS THEN ATTACHED TO THE GENERATOR AND THE TESTING CYCLE COMPLETED. DURING THE PROCEDURE, THE DEVICE STOPPED WORKING, AND IT WAS NOTED THAT PART OF THE ACTIVE BLADE HAD BECOME DETACHED FROM THE DEVICE. IT IS UNK WHETHER THE TIP WAS RETRIEVED. IT WAS NOT AVAILABLE TO BE SENT BACK WITH THE DEVICE. A FOURTH DEVICE WAS THEN OPENED AND USED FOR THE REMAINDER OF THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM GEI ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE