BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 8691800 · Received June 12, 2019

    Report

    Report Number
    3005075853-2019-19663
    Event Type
    Injury
    Date Received
    June 12, 2019
    Report Date
    May 16, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: CENTRAL VENOUS PRESSURE DROP AFTER HYPOVOLEMIC PHLEBOTOMY IS A STRONG INDEPENDENT PREDICTOR OF INTRAOPERATIVE BLOOD LOSS DURING LIVER RESECTION AUTHOR(S): ANDRIES RYCKX, MD, CLAUDINE CHRISTIAENS, MD, MATHIAS CLARYSSE, MD, FRANKY VANSTEENKISTE, MD, PIETER JAN STEELANT, MD, GREGORY SERGEANT, MD, PHD, ISABELLE PARMENTIER, HANS POTTEL, PHD, AND MATHIEU D¿HONDT, MD. CITATION: ANN SURG ONCOL. 2017; 24: 1367¿1375. DOI: 10.1245/S10434-016-5737-7. INTRAOPERATIVE HYPOVOLEMIC PHLEBOTOMY (HP) HAS BEEN SUGGESTED TO REDUCE CENTRAL VENOUS PRESSURE (CVP) BEFORE HEPATECTOMY. THIS STUDY AIMED TO ANALYZE THE IMPACT OF CVP DROP AFTER HP ON INTRAOPERATIVE BLOOD LOSS AND POSTOPERATIVE RENAL FUNCTION. THIS IS A RETROSPECTIVE REVIEW OF A PROSPECTIVE DATABASE INCLUDING 100 CONSECUTIVE PATIENTS (43 MALES AND 57 FEMALES; AGE RANGE: 23 TO 89 YEARS OLD) UNDERGOING LIVER RESECTION WITH HP WAS PERFORMED. DURING THE SURGICAL PROCEDURE AND SINCE 2013, PARENCHYMAL TRANSECTION IN PATIENTS UNDERGOING A LAPAROSCOPIC LIVER RESECTION HAS BEEN PERFORMED USING THE ENSEAL G2 ARTICULATING CURVED TISSUE SEALER (ETHICON), A NEW-GENERATION ARTICULATING CURVED BIPOLAR DEVICE. FOR THE OPEN AND LAPAROSCOPIC LIVER RESECTIONS, IT WAS ALSO REPORTED THAT THE HARMONIC ACE ULTRASONIC SCALPEL (ETHICON) WAS USED. FOR OPEN LIVER SURGERY, PORTAL VEIN HAS BEEN DIVIDED USING THE ECHELON FLEX POWERED VASCULAR STAPLER (ETHICON). IN THE LAPAROSCOPIC LIVER RESECTION GROUP, REPORTED COMPLICATIONS INCLUDED PERI-OPERATIVE INJURY OF THE LEFT HEPATIC VEIN AT THE HEPATO-CAVAL CONFLUENCE (N-1), WHICH WAS PRIMARILY SUTURED. OTHER REPORTED COMPLICATIONS INCLUDED BILOMA (N-1) WHICH WAS MANAGED WITH PERCUTANEOUS DRAINAGE, BILE LEAK (N-1) WHICH WAS MANAGED CONSERVATIVELY, GASTROPARESIS (N-3), WOUND INFECTION (N-2) AND WERE TREATED BY OPENING THE WOUND AT THE BEDSIDE, AND BLOOD LOSS (N-2) WHICH REQUIRED TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS. DROP IN CVP AFTER HYPOVOLEMIC PHLEBOTOMY IS SIGNIFICANTLY CORRELATED WITH EBL DURING HEPATIC RESECTION. THE TECHNIQUE OF HYPOVOLEMIC PHLEBOTOMY IS SAFE AND FEASIBLE, BUT CLOSE MONITORING OF MAP AND POST-OPERATIVE RENAL FUNCTION IS NECESSARY. WE ADVOCATE THE ROUTINE USE OF HP TO REDUCE PERIOPERATIVE BLOOD LOSS AND TRANSFUSION RATES IN LIVER SURGERY. MEASUREMENT OF CVP DROP AS A PREDICTIVE TOOL CAN HELP SURGEONS TO DECIDE WHETHER A LAPAROSCOPIC APPROACH IS SAFE FOR RESECTION OF LESIONS IN PROXIMITY TO THE VENA CAVA, HEPATOCAVAL CONFLUENCE, OR HEPATIC VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485079 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention