BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10566670 · Received September 22, 2020

    Report

    Report Number
    3005075853-2020-04811
    Event Type
    Injury
    Date Received
    September 22, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 9/22/2020 PUBLICATION YEAR OF 2020. 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: CLIPLESS LAPAROSCOPIC CHOLECYSTECTOMY: ULTRASONIC DISSECTION VS CONVENTIONAL METHOD. AUTHORS: LALIGEN AWALE; NARENDRA PANDIT; SHAILESH ADHIKARY. CITATION: WORLD JOURNAL OF LAPAROSCOPIC SURGERY (2020): 10.5005/JP-JOURNALS-10033-1384. WEBSITE: HTTPS://DOI.ORG/10.1186/S12301-019-0003-4. THE AIM OF THIS STUDY WAS TO EVALUATE HOW EFFECTIVE AND SAFE HARMONIC SHEAR IN DIVIDING THE CYSTIC DUCT IN LAPAROSCOPIC CHOLECYSTECTOMY (LC), TO MOVE FORWARD WITH THE TIME, AND TO FIND IF IT ACTUALLY CONFERS BENEFIT IN RELATION TO OPERATIVE TIME, BLEEDING, REDUCED POSTOPERATIVE MORBIDITY. BETWEEN 2015 AND 2016, A TOTAL OF 112 PATIENTS UNDERWENT INTO EITHER CONVENTIONAL LAPAROSCOPY (CL) GROUP (MALE=8, FEMALE=51; MEAN AGE=45.64 ± 14.84 YEARS, AGE RANGE=20 TO 70 YEARS) OR CLIPLESS LAPAROSCOPIC CHOLECYSTECTOMY (CLC) GROUP (MALE=10, FEMALE43; MEAN AGE=45.64 ± 14.84 YEARS, AGE RANGE=20 TO 70 YEARS). DURING THE PROCEDURE IN THE CLC GROUP, THE ULTRACISION HARMONIC SCALPEL (ETHICON) WAS USED FOR DISSECTING THE TRIANGLE OF CALOT. REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE GALLBLADDER (GB) PERFORATION (N=7) IN WHICH 6 PATIENTS REQUIRED PLACEMENT OF DRAIN; POSTOPERATIVE PAIN (N=53) WITH VAS PAIN SCORE AT 12 HOURS OF 3.91 ± 0.94 WHICH REQUIRED ANALGESICS, VAS PAIN SCORE AT 24 HOURS OF 2.5 ± 0.80 WHICH 51 PATIENTS REQUIRED ANALGESICS, AND VAS PAIN SCORE AT 1 WEEK OF 1.17 ± 0.47; BLOOD LOSS DUE TO FALL OF HEMOGLOBIN WITH MEDIAN VALUE OF 0.40 G/DL (0.20 - 0.50 G/DL) (N=53). IN CONCLUSION, WITH THE DEVELOPMENT OF ULTRASONIC ENERGY SOURCE AND ITS ABILITY TO SEAL THE VESSEL AND CYSTIC DUCT SAFELY, IT CAN BE UTILIZED DURING LC WITHOUT THE NEED OF CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029380 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention