BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2894394 · Received January 3, 2013

    Report

    Report Number
    3005075853-2013-00022
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 24, 2012
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE CLAMP ARM DETACHED FROM THE INSTRUMENT OUTER TUBE. THE CLAMP ARM WAS RETURNED IN A PETRI DISH WITH THE TISSUE PAD ATTACHED TO THE CLAMP ARM. THE TISSUE PAD WAS FOUND IN GOOD VISUAL CONDITION. THE OUTER TUBE INTERFACE WITH THE CLAMP ARM WAS FOUND TO BE DAMAGED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR FOR FUNCTIONAL TESTING, BUT COMPLETE TESTING WAS NOT POSSIBLE AS THE CLAMP ARM WAS DETACHED. NO CONCLUSION COULD BE DRAWN AS TO WHAT CAUSED THE CLAMP ARM TO DETACH, HOWEVER PROBABLE CAUSES INCLUDE: NOT CLOSING THE TRIGGER WHEN SLIDING THE TORQUE WRENCH ON AND OFF; NOT CLOSING THE TRIGGER WHEN INTRODUCING OR REMOVING THROUGH THE TROCAR; OR ENTANGLEMENT IN FIBROUS TISSUE. PLEASE NOTE THAT THIS CONDITION IS UNRELATED WITH THE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN CORONARY ARTERY BYPASS GRAFT, THE TISSUE PAD WAS DETACHED OFF. THE FRAGMENTS WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792 ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4C34X

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE