BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9668738 · Received February 4, 2020

    Report

    Report Number
    3005075853-2020-00765
    Event Type
    Injury
    Date Received
    February 4, 2020
    Report Date
    January 7, 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). PUBLICATION YEAR OF 2015. 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: LAPAROSCOPIC CHOLEDOCHOJEJUNOSTOMY IN VARIOUS HEPATOBILIARY AND PANCREATIC SURGERIES: A SINGLE SURGEON¿S EXPERIENCE. AUTHORS: JUN SUH LEE, MD, AND TAE HO HONG, MD. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES. VOLUME 25, NUMBER 4, 2015. DOI: 10.1089/LAP.2014.0539. THE OBJECTIVES OF THIS STUDY WERE TO MEASURE THE LEARNING CURVE FOR LAPAROSCOPIC CHOLEDOCHOJEJUNOSTOMY (LCJ), TO DESCRIBE THE TECHNICAL TIPS, AND TO REPORT THE FOLLOW-UP DATA. EIGHTY FOUR PATIENTS UNDERWENT LCJ BETWEEN SEPTEMBER 2007 AND JULY 2014. OF THE 84 PATIENTS, 2 PATIENTS WERE EXCLUDED FROM THE STUDY, 30 PATIENTS (MEAN AGE - 61.4 ± 10.5 YEARS) WERE INCLUDED IN THE FIRST 3 GROUPS, AND 52 (MEAN AGE - 60.1 ± 11.6 YEARS) WERE INCLUDED IN THE LAST 5 GROUPS. THERE WERE 18 MALES AND 12 FEMALES IN THE FIRST 3 GROUPS AND 30 MALES AND 22 FEMALES IN THE LAST 5 GROUPS. CJ WAS PERFORMED USING A HARMONIC SCALPEL (ETHICON ENDOSURGERY INC.), AN INCISION WAS DONE ON THE ANTIMESENTERIC SIDE OF THE ANCHORED ROUX LIMB. WHEN LAPAROSCOPIC ROUX-EN-Y CHOLEDOCHOJEJUNOSTOMY WAS PERFORMED IN PATIENTS WITH RECURRENT CHOLEDOCHOLITHIASIS, THE JEJUNUM APPROXIMATELY 50¿60 CM DISTAL TO THE TREITZ LIGAMENT WAS SEPARATED USING AN ENDO-GIA STAPLER SIX PATIENTS DEVELOPED POSTOPERATIVE BILE LEAKAGE. OF THESE 6 PATIENTS, 5 HAD GRADE A BILE LEAKAGE AND ONE HAD GRADE B BILE LEAKAGE THAT REQUIRED ADDITIONAL PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE AND CATHETER INSERTION. TEN PATIENTS HAD BILIARY STRICTURES, OVER THE 82-MONTH FOLLOW-UP PERIOD. IN CONCLUSION, THE AUTHORS REPORTED THAT LCJ IS A SAFE AND FEASIBLE PROCEDURE THAT CAN BE USED IN MANY PROCEDURES IN THE FIELD OF HEPATOBILIARY AND PANCREATIC SURGERY. AFTER A CERTAIN LEARNING CURVE, EXPERIENCED SURGEONS CAN PERFORM LCJ WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126823 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention