BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9629804 · Received January 24, 2020

    Report

    Report Number
    3005075853-2020-00549
    Event Type
    Injury
    Date Received
    January 24, 2020
    Report Date
    January 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: (B)(6)2020. H10: CORRECTED DATA = H1 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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THE ETHICON HARMONIC DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POST-OPERATIVE ISSUES TO INCLUDE THE PATIENT DEATH? IF SO, WHY OR WHY NOT? NO. ACTUALLY WE WERE USING THE HARMONIC SCALPEL ACE + 7 IN A SWINGING MANEUVER AND IT'S ESPECIALLY USEFUL FOR MACRONODULAR CIRRHOTIC LIVER, WHICH OTHER ENERGY DEVICE CANNOT PROVIDE THE SAME RESULT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2016. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 AUTHOR/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

    TITLE: LEARNING CURVE FOR LAPAROSCOPIC MAJOR HEPATECTOMY: USE OF THE CUMULATIVE SUM METHOD AUTHOR/S: FIONA KA-MAN CHAN, KAI-CHI CHENG, YUK-PANG YEUNG AND KIT-MAN HO CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2016;26:E41¿E45 THIS STUDY AIMED TO INVESTIGATE THE FEASIBILITY AND SAFETY OF LMRS BY LEARNING CURVE ANALYSIS. A TOTAL OF 151 PATIENTS UNDERWENT 156 LLRS FROM 2002 TO 2014. THERE WERE 49 MAJOR HEPATECTOMIES (MEDIAN AGE 65 YEARS, MALE N=37, FEMALE N=12) AND 107 MINOR HEPATECTOMIES (MEDIAN AGE YEARS, MALE N=71 AND FEMALE N=36). FIVE PORTS WERE USED AND PLACED ACCORDING TO TUMOR LOCATION. PARENCHYMAL DISSECTION WAS PERFORMED BY CAVITRON ULTRASONIC SURGICAL ASPIRATOR (VALLEYLAB INC., BOULDER, CO), HARMONIC SCALPEL (HARMONIC ACE; ETHICON ENDOSURGERY, JOHNSON & JOHNSON, LANGHORNE, PA), OR LIGASURE (VALLEYLAB). COMPLICATIONS INCLUDED FAILED DISSECTION OF PEDICLE (N=3) AND BLEEDING (N=4) WHICH LEAD TO CONVERSION TO OPEN SURGERY. FURTHER COMPLICATIONS INCLUDED BILE LEAK (N=7), THREE WERE MANAGED CONSERVATIVELY, 2 REQUIRED ENDOBILIARY AND IMAGE-GUIDED DRAINAGE, AND 2 REQUIRED RELAPAROTOMY: ONE PATIENT AFTER LAPAROSCOPIC ASSISTED LEFT HEPATECTOMY REQUIRED LAPAROTOMY FOR CONTROL OF BILE LEAK FROM SEGMENTAL DUCTS AND T-TUBE FOR DRAINAGE; THE SECOND WAS THE RESULT OF DUODENAL PERFORATION (N=1) REQUIRING PATCH REPAIR; INFECTED ASCITES (N=1) WHICH REQUIRED RELAPAROTOMY AND EXTENSIVE BOWEL ISCHEMIA (N=1) REQUIRING REOPERATION AND RESULTED IN MORTALITY. IN CONCLUSION, LAPAROSCOPIC MAJOR RESECTION IS SAFE AND FEASIBLE; OPERATIVE OUTCOMES IMPROVED AFTER OVERCOMING THE LEARNING CURVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91467 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention