BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGY CAPITAL GENERATOR 11

    MDR report key: 2980046 · Received February 27, 2013

    Report

    Report Number
    3005075853-2013-00868
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOT REPORTABLE - FILING SERIOUS INJURY ON DISPOSABLE - SEE 3005075853-2013-01053 ADDITIONAL INFORMATION RECEIVED: HOW MUCH BLOOD WAS LOST? 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? 4 UNITS. DID THE BLEEDING OCCUR INTRA-OP OR POST OP? 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? 3MM APPROX. DID THE SURGEON COMPLETE THE PROCEDURE WITH A DIFFERENT GEN11 OR A GEN04? GEN11. THE FOLLOWING ADDITIONAL INFORMATION IS NEEDED: HOW LONG HAS THE SURGEON AND ACCOUNT BEEN USING THE GEN11? 2 MONTHS APPROX. DID THE GEN11 DISPLAY ANY YELLOW ALERT SCREENS DURING THE PROCEDURE? NO. IF YES, WHAT TROUBLESHOOTING WAS DONE? WHAT MODALITY WAS THE GEN11 BEING USED IN, HARMONIC OR ENSEAL? IF HARMONIC: WHAT POWER SETTING WAS THE GENERATOR ON? 3. WAS THE POWER LEVEL OF THE GENERATOR CHANGED TO ACHIEVE BETTER CUTTING AND/OR COAGULATION? NO. WHAT DISPOSABLE(S) WAS BEING USED? (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT ADDITIONAL INFORMATION REQUESTED: REGARDING THIS: "THERE WAS BLEEDING WITH SEVERAL PATIENTS." REGARDING THIS: "ONE PATIENT RECEIVED A TRANSFUSION. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE." HOW MUCH BLOOD WAS LOST? WHERE WAS THE BLEEDING FROM? (STATE WHERE). HOW WAS THE BLEEDING CONTROLLED? HOW MUCH BLOOD WAS TRANSFUSED? DID THE BLEEDING OCCUR INTRA-OP OR POST OP? IF POST OP: HOW LONG AFTER THE ORIGINAL PROCEDURE DID THE BLEEDING OCCUR (PROVIDED NUMBER OF HOURS, DAYS, ETC.). WAS THE SURGICAL FIELD INSPECTED AND FOUND TO BE DRY (NO BLEEDING) WHEN THE PATIENT WAS CLOSED? WHAT WAS THE SIZE OF THE VESSEL OR ARTERY? DID THE SURGEON COMPLETE THE PROCEDURE WITH A DIFFERENT GEN11 OR A GEN04? THE FOLLOWING ADDITIONAL INFORMATION IS NEEDED: HOW LONG HAS THE SURGEON AND ACCOUNT BEEN USING THE GEN11? DID THE GEN11 DISPLAY ANY YELLOW ALERT SCREENS DURING THE PROCEDURE? IF YES, WHAT TROUBLESHOOTING WAS DONE? WHAT MODALITY WAS THE GEN11 BEING USED IN, HARMONIC OR ENSEAL? IF HARMONIC: WHAT POWER SETTING WAS THE GENERATOR ON? WAS THE POWER LEVEL OF THE GENERATOR CHANGED TO ACHIEVE BETTER CUTTING AND/OR COAGULATION? IF ENSEAL, DID THE SURGEON HEAR THE TONE CHANGES? TONE 1 IS HEARD WHEN THE ENERGY ACTIVATION BUTTON IS PRESSED. PRESSING THE ENERGY ACTIVATION BUTTON ENERGIZES THE JAWS AND BEGINS COAGULATION OF THE TARGETED TISSUE. TONE 1 IS HEARD AS ENERGY IS DELIVERED TO THE GRASPED TISSUE. TONE 2 IS HEARD WHEN TISSUE IMPEDANCE THRESHOLD IS REACHED. THIS IS WHEN THE TISSUE IS TRANSECTED AND THE TISSUE COLLAPSES DURING COAGULATION. THE I-BLADE KNIFE IS READY TO BE FULLY ADVANCED. TONE 3 IS HEARD WHEN THE CYCLE IS COMPLETE. AFTER THE CLOSING HANDLE IS FULLY CLOSED, THE I-BLADE KNIFE IS FULLY ADVANCED, AND THE TISSUE IMPEDANCE THRESHOLD HAS BEEN REACHED, THE CYCLE IS COMPLETE AND AUTOMATICALLY STOPS DELIVERY OF ENERGY WHAT DISPOSABLE(S) WAS BEING USED? WHAT OTHER INSTRUMENTS WERE USED DURING THE SURGERY? PATIENT SPECIFIC QUESTIONS: WAS THE PATIENT TAKING ANY ANTICOAGULANTS, SUCH AS ASPIRIN, ANTICOAGULANTS, OR ANTIPLATELET AGENTS)? IF YES, SPECIFY PRESCRIBED MEDICATION. HAS THE PATIENT UNDERGONE ANY RADIATION/CHEMOTHERAPY THERAPY? IF YES, PLEASE SPECIFY RADIATION, CHEMO, OR BOTH. DOES THE PATIENT HAS A KNOWN COAGULATION DISORDER? HAS THE PT TAKEN ANY STEROIDS? WHAT WAS THE PATIENT'S PRE-OP HEMOGLOBIN AND HEMATOCRIT? WHAT WAS THE PATIENT'S POST OPERATIVE HEMOGLOBIN AND HEMATOCRIT? WHAT IS THE CURRENT PATIENT CONDITION? WILL THE GENERATOR BE RETURNED FOR REPAIR/SERVICE? IF YES, WILL THE GENERATOR BE SENT TO THE SERVICE CENTER IN (B)(6) OR TO THE UNITED STATES. IF TO THE UNITED STATES, A PURCHASE ORDER # WILL BE NEEDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE COMPLAINT SHOULD BE AGAINST THE DISPOSABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83732 ENERGY CAPITAL GENERATOR 11 INSTRUMENT, ULTRASONIC SURGIICAL GEI ETHICON ENDO-SURGERY, LLC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention