BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE ATT

    MDR report key: 2982462 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00906
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED FROM SURGEON: WHAT WAS THE ESTIMATED DIAMETER OF THE BLOOD VESSEL? 3-5MM SHORT GASTRIC ON SHORT BUT UNKNOWN LENGTH. STUMP OF ARTERY LESS THAN 5MM OFF OF FEEDING BRANCH OF SUPERIOR POLE SPLENIC ARTERY BRANCH. LOVENOX IS USED FOR DVT AND ALTERS THE BLOOD'S ABILITY TO CLOT - DID THE PATIENT HAVE A HISTORY OF DEVELOPING BLOOD CLOTS? {PATIENT WAS ONLY ON DVT PROPHYLAXIS LOVENOX THERAPY. SHE WAS NOT THERAPEUTICALLY ANTICOAGULATED. IS THE LOVENOX SUSPECTED AS CAUSING THE POST-OP BLEED? IF YES, WAS THIS ADVERSE EVENT REPORTED TO THE FDA AND/OR MANUFACTURER OF LOVENOX? NO. I HAVE NO INDICATION THAT LOVENOX WAS THE CAUSE OF BLEED. IT IS MY ASSUMPTION THAT PATIENT HAD VIGOROUS RESPONSE TO LOVENOX ANY MAY HAVE CONTRIBUTED BUT IT WAS OBVIOUS THAT VESSEL WAS NOT ADEQUATELY SEALED WAS THE PATIENT'S BLOOD COUNT MONITORED POST-SURGERY? YES ROUTINE AM LABS WERE DRAWN. HCT WAS STABLE ON POD1 HOWEVER IT DROPPED ABOUT 10 HCT POINTS BY AM OF POD2. WHAT IS THE CURRENT PATIENT CONDITION? STABLE AND RECOVERING. DISCHARGED HOME WITHOUT FURTHER INCIDENT. WHAT DOES THE SURGEON BELIEVE CAUSED THE POST-OP BLEED? I BELIEVE DIFFICULT ANATOMY COMBINED WITH UNFAMILIARITY WITH THE NEW INSTRUMENT WAS THE PRIMARY ISSUE. I CAN NOT SAY THIS WOULD NOT HAVE HAPPENED WITH STANDARD HARMONIC SCALPEL HOWEVER OPERATOR UNFAMILIARITY WITH THIS INSTRUMENT CERTAINLY DID NOT HELP AND SEALING OF VESSEL WAS CERTAINLY NOT ADEQUATE. OTHER CONTRIBUTING FACTORS COULD ALSO HAVE BEEN AN INTERVAL OF RETCHING BY PATIENT (HYPERTENSION) THAT PRECEDED THE DROP IN HCT(BLEED) AND APPARENT VIGOROUS RESPONSE TO LOVENOX AS EVIDENCED BY BRUISING AT INJECTION SITES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE PROCEDURE WAS COMPLETED WITH ONE DEVICE WITHOUT INCIDENT. ON POST-OP DAY THREE ((B)(6) 2013), THE PATIENT REQUIRED A SECOND OPERATION TO ADDRESS INTERNAL BLEEDING ORIGINATING FROM A SHORT GASTRIC ARTERY NEAR THE SPLEEN. THE PATIENT IS STABLE AND IS RECEIVING ADDITIONAL BLOOD PRODUCTS TO ADDRESS THE BLOOD LOSS (ESTIMATED AT 2000-3000 CC'S). THE INITIAL PROCEDURE WAS COMPLETED WITH THE ORIGINAL HAR36 INSTRUMENT. THE SURGEON USED A LIGATING CLIP TO CLOSE THE VESSEL DURING THE RE-OPERATION. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86866 HARMONIC ACE ATT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE