BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9414028 · Received December 4, 2019

    Report

    Report Number
    3005075853-2019-23983
    Event Type
    Injury
    Date Received
    December 4, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR OF 2014 FOR JOURNAL ARTICLE. 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: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON 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: LAPAROSCOPIC CHOLECYSTECTOMY: ULTRASONIC ENERGY VERSUS MONOPOLAR ELECTROSURGICAL ENERGY AUTHORS: A. ZANGHÌ, A. CAVALLARO, P. DI MATTIA, M. DI VITA, F. CARDÌ, G. PICCOLO, G. BARBERA, R. FISICHELLA, D. SPARTÀ, A. CAPPELLANI CITATION: EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES. 2014; 18 (SUPPL 2): 54-59. NOWADAYS, LAPAROSCOPIC CHOLECYSTECTOMY (LC) IS UNDOUBTEDLY CONSIDERED THE ¿GOLD STANDARD¿ IN THE SURGICAL TREATMENT OF SYMPTOMATIC GALLSTONES, GALLBLADDER ADENOMAS AND ACUTE CHOLECYSTITIS. THIS STUDY INVESTIGATES THE POSSIBLE BENEFICIAL ASPECTS OF ULTRASONIC DISSECTION AND ITS EFFICACY IN THE CLOSURE OF THE CYSTIC ARTERY AND DUCT. A TOTAL OF 164 PATIENTS (68 MALE AND 96 FEMALE PATIENTS; AGE RANGE: 18 TO 80 YEARS OLD) WERE RETROSPECTIVELY DIVIDED INTO 2 GROUPS ACCORDING TO THE INSTRUMENTS USED FOR DIVISION OF THE CYSTIC ARTERY AND DUCT AS WELL AS FOR DISSECTION OF THE LIVER BED. A TOTAL OF 121 PATIENTS IN WHOM DISSECTION AND COAGULATION (GROUP A) AND 43 PATIENTS WHO WERE ALL TREATED WITH THE HARMONIC ACE SCALPEL (ETHICON) AS THE SOLE INSTRUMENT USED IN THE WHOLE PROCEDURE (GROUP B). LC WAS DONE BY DISSECTION OF CALOT¿S TRIANGLE AND THEN OCCLUSION OF BOTH CYSTIC DUCT AND ARTERY USING THE HARMONIC ACE SCALPEL (ETHICON). WHEN DISSECTING THE GALLBLADDER FROM ITS BED, THE AUTHORS SET IT TO LEVEL 5 (MORE CUTTING POWER, LESS COAGULATION), AND CONTROL OF ANY BLEEDING FROM THE BED USING THE ACTIVE BLADE OF THE HARMONIC ACE SCALPEL (ETHICON). REPORTED COMPLICATIONS INCLUDED BLOOD LOSS (N-1) WHICH REQUIRED SURGICAL TREATMENT, GALLBLADDER PERFORATION (N-3), AND HEMOPERITONEUM (N-1) WHICH REQUIRED LAPAROTOMY. THE USE OF THE HARMONIC SCALPEL SHOWS SOME STATISTICALLY SIGNIFICANT ADVANTAGES LIMITED TO A FEW INTRAOPERATIVE PARAMETERS. THE AUTHORS CONCLUDED THAT A WIDER USE OF HARMONIC SCALPEL NOT OFFERS SUCH ADVANTAGES TO MAKE IT THE REFERENCE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208276 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention