BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2990876 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01053
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    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. ADDITIONAL INFORMATION: HOW MUCH BLOOD WAS LOST? A 2,000CC. WHERE WAS THE BLEEDING FROM? (STATE WHERE) LESSER CURVATURE. HOW WAS THE BLEEDING CONTROLLED? PATIENT REQUIRES ANOTHER SURGERY. HOW MUCH BLOOD WAS TRANSFUSED? FOUR UNITS. DID THE BLEEDING OCCUR INTRA-OP OR POST OP? POST OP. IF POST OP: HOW LONG AFTER THE ORIGINAL PROCEDURE DID THE BLEEDING OCCUR (PROVIDED NUMBER OF HOURS, DAYS, ETC.) HOURS. WAS THE SURGICAL FIELD INSPECTED AND FOUND TO BE DRY (NO BLEEDING) WHEN THE PATIENT WAS CLOSED? YES. WHAT WAS THE SIZE OF THE VESSEL OR ARTERY? AT 3MM APROX. DID THE SURGEON COMPLETE THE PROCEDURE WITH A DIFFERENT GEN11 OR A GEN04? GEN11. HOW LONG HAS THE SURGEON AND ACCOUNT BEEN USING THE GEN11? TWO MONTHS APROX. DID THE GEN11 DISPLAY ANY YELLOW ALERT SCREENS DURING THE PROCEDURE? NO. IF YES, WHAT TROUBLESHOOTING WAS DONE? (NO ANSWER GIVEN). WHAT MODALITY WAS THE GEN11 BEING USED IN, HARMONIC OR ENSEAL? IF HARMONIC: WHAT POWER SETTING WAS THE GENERATOR ON? THREE. WAS THE POWER LEVEL OF THE GENERATOR CHANGED TO ACHIEVE BETTER CUTTING AND/OR COAGULATION? NO. WHAT DISPOSABLE(S) WAS BEING USED? ACE36E. PATIENT SPECIFIC QUESTIONS: WAS THE PATIENT TAKING ANY ANTICOAGULANTS, SUCH AS ASPIRIN, ANTICOAGULANTS, OR ANTIPLATELET AGENTS)? IF YES, SPECIFY PRESCRIBED MEDICATION. NO. HAS THE PATIENT UNDERGONE ANY RADIATION/CHEMOTHERAPY THERAPY? IF YES, PLEASE SPECIFY RADIATION, CHEMO, OR BOTH. NO. DOES THE PATIENT HAS A KNOWN COAGULATION DISORDER? NO. HAS THE PATIENT TAKEN ANY STEROIDS? NO. WHAT WAS THE PATIENT'S PRE-OP HEMOGLOBIN AND HEMATOCRIT? GREATER THAN 13. WHAT WAS THE PATIENT'S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? SIX. WHAT IS THE CURRENT PATIENT CONDITION? STABLE. WILL THE GENERATOR BE RETURNED FOR REPAIR/SERVICE? YES TO US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS BLEEDING WITH SEVERAL PATIENTS, ONE PATIENT RECIEVED A TRANSFUSION.THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95767 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE