BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 8901478 · Received August 16, 2019

    Report

    Report Number
    3005075853-2019-21283
    Event Type
    Injury
    Date Received
    August 16, 2019
    Report Date
    September 7, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED FROM AUTHOR, IOANNIS D. KOSTAKIS, M.D. ON 9/7/2019: OUR ARTICLE WAS AN ATTEMPT TO COMPARE TWO DIFFERENT ULTRASONIC SCALPELS IN TERMS OF POSTOPERATIVE BILE LEAK AND BLEEDING. BOTH THESE TWO POSTOPERATIVE COMPLICATIONS ARE EXPECTED AFTER LIVER RESECTIONS, WITH RATES AROUND 4-17% AND 4-10% RESPECTIVELY IN THE LITERATURE. OUR ANALYSIS SHOWED THAT THERE IS NO ACTUAL DIFFERENCE IN THE OUTCOMES OF THESE TWO ULTRASONIC SCALPELS AND THE NUMBERS IN OUR SERIES WERE WITHIN THE ONES DESCRIBED IN THE LITERATURE. THEREFORE, THERE IS NO EVIDENCE FROM OUR STUDY THAT THESE CASES OF POSTOPERATIVE BLEEDING OR BILE LEAK CAN BE ATTRIBUTED TO EITHER LOTUS OR HARMONIC ULTRASONIC SCALPELS. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE - BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION: DOES THE SURGEON BELIEVE THAT THE ETHICON HARMONIC ACE + DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF A JOURNAL ARTICLE: TITLE: IMPACT OF ULTRASONIC SCALPELS FOR LIVER PARENCHYMAL TRANSECTION ON POSTOPERATIVE BLEEDING AND BILE LEAKAGE. AUTHOR(S): IOANNIS D. KOSTAKIS, NIKOLAOS MACHAIRAS, ZOE GAROUFALIA, ANASTASIA PRODROMIDOU AND GEORGIOS C. SOTIROPOULOS. CITATION: IN VIVO 32: 883-886 (2018) / DOI:10.21873/INVIVO.11323. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO COMPARE TWO TYPES OF ULTRASONIC SCALPELS (LOTUS AND HARMONIC) AND EXAMINE HOW THEY PERFORM EITHER ALONE OR IN COMBINATION WITH THE SONASTAR ULTRASONIC SURGICAL ASPIRATION SYSTEM REGARDING POSTOPERATIVE BLEEDING AND BILE LEAKAGE. A TOTAL OF 102 PATIENTS [N=61 MALE, N=41 FEMALE, MEAN AGE 60.6 ±12.8 YEARS; RANGE (19-86 YEARS); MEAN BMI 26.4±3.7 KG/M2] WITH SOLID LIVER LESIONS UNDERWENT LIVER RESECTION. THE PATIENTS WERE DIVIDED INTO FOUR GROUPS ACCORDING TO THE DEVICES THAT WERE USED FOR LIVER PARENCHYMAL TRANSECTION: GROUP 1, PERFORMED WITH LOTUS LIVER RESECTOR ALONE (N=32); GROUP 2, PERFORMED WITH LOTUS LIVER RESECTOR AND SONASTAR ULTRASONIC SURGICAL ASPIRATION SYSTEM (N=27); GROUP 3, PERFORMED WITH HARMONIC ACE +7 SHEARS ALONE (N=27); AND GROUP 4, PERFORMED WITH HARMONIC ACE +7 SHEARS AND SONASTAR ULTRASONIC SURGICAL ASPIRATION SYSTEM (N=16). IN GROUPS 3 AND 4, HARMONIC ACE +7 WAS USED FOR LIVER RESECTION. COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N=1) TREATED CONSERVATIVELY WITH TRANSFUSION OF BLOOD AND FRESH FROZEN PLASMA; AND POSTOPERATIVE BILE LEAKAGE (N=4) TREATED WITH SOME FORM OF INTERVENTION, BUT WITHOUT REQUIRING GENERAL ANESTHESIA. BOTH LOTUS AND HARMONIC ULTRASONIC SCALPELS PROVIDE ADEQUATE AND SIMILAR RESULTS CONCERNING POSTOPERATIVE HEMORRHAGE AND CHOLORRHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697115 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE| GENERATOR AND HANDPIECE