BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL CURVED SHEARS

    MDR report key: 4203578 · Received October 27, 2014

    Report

    Report Number
    3005075853-2014-07388
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 17, 2014
    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). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED WITH THE CLAMP ARM DETACHED FROM THE INSTRUMENT AND NOT RETURNED. AS A RESULT OF THE CLAMP ARM DETACHMENT, THE TUBE ASSEMBLY WAS DISTORTED. THE TISSUE PAD COULD NOT BE INSPECTED DUE TO THE CLAMP ARM WAS NOT RETURNED AND THE TISSUE PAD IS EMBEDDED TO CLAMP ARM. 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). 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 CORONARY ARTERY BYPASS GRAFT, THE TISSUE PAD WAS DETACHED OFF. NO PIECES FELL INTO THE PATIENT. 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
    681688 HARMONIC SCALPEL CURVED SHEARS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4E003

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE