BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15540089 · Received October 4, 2022

    Report

    Report Number
    3005075853-2022-06684
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    September 17, 2020
    Report Date
    October 4, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/4/2022. DATE OF EVENT: 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 10/24/2022 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN . YES, MANY SURGEONS BELIEVE NOT ONLY THE ETHICON DEVICES COULD HARM THE BILIARY SYSTEM BUT ANY OTHER ENERGY DEVICE COULD DO SO. (WE CORRECT THIS CONCEPT IN OUR ARTICLE AND ENCOURAGE SURGEONS TO USE HARMONIC DEVICES.) 2. WE USED THE OLD VERSION OF THE HARMONIC DEVICE (ETHICON ENDOSURGERY, CINCINNATI, OHIO). 3. NO. NONE BELIEVED THAT THERE WAS A DEFICIENCY IN THE ETHICON DEVICES, BUT THEY BELIEVED THAT EXCESSIVE HEAT DENATURATES THE SURROUNDING TISSUES AND DESTROYS THE DUCT SYSTEM, MAKING POSTOPERATIVE BILIARY LEAKAGE AND STRICTURE COMMON POSTOPERATIVE COMPLICATIONS (AND THIS WAS A WRONG CONCEPT).

    Description of Event or Problem · 0

    TITLE: IMPACT OF CHOLEDOCHOTOMY TECHNIQUES DURING LAPAROSCOPIC CBD EXPLORATION ON SHORT- AND LONG-TERM CLINICAL OUTCOMES: TIME TO CHANGE CONCEPTS (A RETROSPECTIVE COHORT STUDY) . AUTHORS: EMAD ALI AHMED, MD, PHD, ALAA AHMED REDWAN, MD, PHD . CITATION: INTERNATIONAL JOURNAL OF SURGERY 83 (2020) 102¿106, HTTPS://DOI.ORG/10.1016/J.IJSU.2020.08.043 . THIS STUDY AIMED TO RETROSPECTIVELY ANALYZE AND COMPARE THE IMPACT OF CHOLEDOCHOTOMY TECHNIQUES DURING LCBDE AMONG PATIENTS WITH CHOLEDOCHOLITHIASIS DURING THE EARLY AND LATE POSTOPERATIVE PERIODS. FROM MARCH 2014 TO FEBRUARY 2018, 85 PATIENTS WITH CHOLEDOCHOLITHIASIS WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE TREATED BY LAPAROSCOPIC COMMON BILE DUCT EXPLORATION USING VARIOUS CHOLEDOCHOTOMY TECHNIQUES, INCLUDING AN UNKNOWN MANUFACTURER SCALPEL OR SCISSOR (28 PATIENTS) IN GROUP I, AN UNKNOWN MANUFACTURE DIATHERMY HOOK (35 PATIENTS) IN GROUP II, OR AN ULTRASONIC DEVICE (22 PATIENTS) IN GROUP III. GROUP I CONSISTED OF 17 FEMALES AND 11 MALES WITH A MEAN AGE OF 44.79 ± 10.77 YEARS AND UNDERWENT CHOLEDOCHOTOMY PROCEDURE USING AN UNKNOWN MANUFACTURER SCALPEL/SCISSOR. GROUP II CONSISTED OF 19 FEMALES AND 16 MALES WITH A MEAN AGE OF 48.23 ± 12.30 YEARS AND UNDERWENT CHOLEDOCHOTOMY PROCEDURE USING AN UNKNOWN MANUFACTURER DIATHERMY HOOK. GROUP III CONSISTED OF 16 FEMALES AND 6 MALES WITH A MEAN AGE OF 46.82 ± 6.86 YEARS AND THESE PATIENTS UNDERWENT CHOLEDOCHOTOMY USING ULTRACISION HARMONIC SCALPEL (ETHICON ENDO-SURGERY). STONE EXTRACTION WAS DONE EITHER THROUGH CHOLEDOCHOSCOPIC REMOVAL OR BY DIRECT METHODS, INCLUDING COMMON BILE DUCT MILKING AND STONE GRASPING, DORMIE BASKET, BALLOON EXTRACTION IRRIGATION/SUCTION, OR COMBINED TECHNIQUE. THE CLOSURE WAS PERFORMED USING A PDS 4/0 SUTURE (ETHICON). THE REPORTED COMPLICATIONS INCLUDED BILIARY LEAKAGE (N=1). IN CONCLUSION, THE LONG-LASTING CONCEPTS OF AVOIDANCE OF USING ENERGY MACHINES SUCH AS DIATHERMY AND ULTRASONIC DEVICES WITH BILIARY STRUCTURES SHOULD BE CHANGED. HOWEVER, A STATISTICAL TYPE I ERROR CANNOT BE EXCLUDED BECAUSE OF THE SMALL SAMPLE SIZE. THEREFORE, FURTHER ANALYSIS OF PROSPECTIVE RANDOMIZED STUDIES WITH A LARGER NUMBER OF PARTICIPANTS IS STRONGLY RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394939 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GENERATOR