BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3253114 · Received July 29, 2013

    Report

    Report Number
    3005075853-2013-03800
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 5, 2013
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH THE CLAMP ARM DETACHED FROM THE INSTRUMENT. THE TUBE ASSEMBLY WHERE THE CLAMP ARM ATTACHES WAS INSPECTED AND IT WAS DISTORTED, THIS OCCURRED WHEN THE CLAMP ARM WAS REMOVED FROM THE TUBE ASSEMBLY. THE DEVICE WAS PARTIALLY TESTED WITH A GENERATOR AND THE DEVICE PERFORMED AS REQUIRED DURING TESTING; THOUGH ALL TESTING COULD NOT BE COMPLETED DUE TO THE CONDITION OF THE RETURNED DEVICE. POSSIBLE CAUSES OF THE CLAMP ARM DETACHMENT ARE NOT CLOSING THE TRIGGER WHEN SLIDING THE TORQUE WRENCH ON AND OFF; NOT CLOSING THE TRIGGER WHEN INTRODUCING OR REMOVING THROUGH THE TROCAR; OR POSSIBLE ENTANGLEMENT IN FIBROUS TISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). ASSUMED 1ST DAY OF MONTH THAT COMPLAINT WAS REPORTED. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STRUMA PROCEDURE THE CLAMP ARM BROKE AFTER A SHORT TIME, PART DID NOT FALL INTO PATIENT. NO FURTHER INFORMATION IS AVAILABLE. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353318 ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE