BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL CURVED SHEARS

    MDR report key: 4852817 · Received June 18, 2015

    Report

    Report Number
    3005075853-2015-03703
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    June 2, 2015
    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). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. BATCH #L92C80. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND IT WAS RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED, AND WITH EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 AN ALERT SCREEN WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN ALERT SCREEN IS BLADE DAMAGE. PROBABLE CAUSES OF BLADE DAMAGE, INCLUDING BREAKAGE, ARE EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE, BLADE CONTACT WITH OTHER DEVICES, STAPLES OR CLIPS DURING THE PROCEDURE OR USING ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE BLADE. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿, ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. 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 SLEEVE GASTRECTOMY PROCEDURE, AFTER THIRTY MINUTE, THE BLADE BROKE. THE PART FELL INTO THE PATIENT AND COULD BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398378 HARMONIC SCALPEL CURVED SHEARS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4FC4C

    Patients

    Seq Age Sex Outcome Treatment
    1