BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS

    MDR report key: 2852774 · Received November 30, 2012

    Report

    Report Number
    3005075853-2012-05400
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSISSHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF PHOTOGRAPH OF DEVICE. PHOTO ATTACHED THERE WAS NO SAMPLE RECEIVED FOR ANALYSIS. ONLY IMAGES WERE SENT FOR REVIEW. A REVIEW OF THE IMAGE IDENTIFIED THAT THE CLAMP ARM WAS DETACHED FROM THE INSTRUMENT. IT WAS ALSO NOTED THAT THE OUTER TUBE WAS DAMAGED AT THE CLAMP ARM INTERFACE. NO FURTHER TESTS COULD BE PERFORMED DUE TO THE DEVICE WAS NOT RECEIVING. 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

    ADDITIONAL INFORMATION RECEIVED: THE DEVICE IS MISSING THE ENTIRE CLAMP ARM, WHICH REP WAS INFORMED WAS LEFT BEHIND IN THE PATIENT AFTER WEIGHING THE RISKS OF TRYING TO RETRIEVE IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENTRAL HERNIA REPAIR PROCEDURE, THE CLAMP ARM FELL OFF OF THE DEVICE AND INTO THE PATIENT. THE MISSING PIECE WAS LOCATED AND REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1