BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL CURVED SHEARS

    MDR report key: 3121710 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02443
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 30, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED: THE CLAMP ARM BECAME DETACHED. IT WAS RETRIEVED AND SUBMITTED WITH THE DEVICE. THE DEVICE WAS RECEIVED WITH THE CLAMP ARM DETACHED FROM THE INSTRUMENT OUTER TUBE. THE OUTER TUBE INTERFACE WITH THE CLAMP ARM WAS FOUND TO BE DAMAGED. THE CLAMP ARM WAS NOT RETURNED WITH THE DEVICE. NO FURTHER TESTS COULD BE PERFORMED DUE TO THE DEVICE RECEIVING CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON RESECTION, THE IN-ACTIVE PAD DETACHED WHEN IT WAS BEING CLEANED. A SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223889 HARMONIC SCALPEL CURVED SHEARS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4CH4W

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE