BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9766325 · Received February 27, 2020

    Report

    Report Number
    3005075853-2020-01296
    Event Type
    Injury
    Date Received
    February 27, 2020
    Report Date
    January 30, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2008. 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.

    Description of Event or Problem · 1

    TITLE: USEFULNESS OF THE ULTRASONICALLY ACTIVATED SCALPEL IN LAPAROSCOPIC CHOLECYSTECTOMY: OUR EXPERIENCE AND REVIEW OF LITERATURE, AUTHORS: V. MINUTOLO, G. GAGLIANO, C. RINZIVILLO, G. LI DESTRI, M. CARNAZZA, O. MINUTOLO; CITATION: G CHIR VOL. 29 - N. 5 - PP. 242-245 MAGGIO 2008. THE AIM OF OUR STUDY WAS TO COMPARE THE TWO METHODS FOR THE BINDING AND FOR THE SECTION OF THE CYSTIC DUCT AND THE CYSTIC ARTERY DURING THE DISSECTION OF THE GALLBLADDER FROM THE LIVER BED, TO EVALUATE AVERAGE DURATION OF THE OPERATIVE TIME, THE INTRA-OPERATIVE AND POST-OPERATIVE COMPLICATIONS, BLEEDING AND PERCENTAGE OF CONVERSION IN OPEN CHOLECYSTECTOMY. IN THE LAST TWO YEARS, A TOTAL OF 152 PATIENTS WITH GALLBLADDER LITHIASIS WERE TRADITIONALLY OPERATED (N=12) OR UNDERWENT LAPAROSCOPIC PROCEDURE (N=140). OF THE PATIENTS WHO HAD LAPAROSCOPIC PROCEDURE, 50 PATIENTS USED HARMONIC SCALPEL BOTH FOR CLOSING OF THE CYSTIC DUCT AND THE CYSTIC ARTERY AND FOR DISSECTION OF THE GALLBLADDER FROM THE LIVER BED, WHILE 90 PATIENTS THE BINDING AND SECTION BOTH OF THE CYSTIC DUCT AND OF THE CYSTIC ARTERY HAS BEEN PERFORMED WITH USE OF CLIPS AND WITHOUT USE OF HARMONIC SCALPEL. IN HARMONIC SCALPEL GROUP, BOTH ETHICON ULTRACISION AND TYCO/ USSC AUTOSONIX WERE USED WITHOUT SUBSTANTIAL DIFFERENCES BETWEEN THESE TWO KINDS OF HARMONIC SCALPELS. TWO PATIENTS SHOWED LOSS OF BILE BY THE DRAINAGE WHICH WAS DUE TO MISSED SEALING OF THE CLIPSES ON THE CYSTIC DUCT (N=1) AND DUE TO INJURY OF THE BILIARY ACCESSORY SMALL DUCT (N=1). BOTH COMPLICATIONS RESOLVED BY ENDOSCOPIC PAPILLOSPHINCTEROTOMY. IN HARMONIC SCALPEL GROUP, ONLY 2 CASES HAD BLEEDING. THE USE OF THE HS HAS ALLOWED TO OBTAIN A SMALLER INCIDENCE OF COMPLICATIONS BOTH DURING AND AFTER OPERATION BUT, ABOVE ALL, TO REDUCE NOTABLY THE BLEEDING FROM THE LIVER BED (1,4% VERSUS 6,4%, HS-CASE VS. CONTROLS) AND THE INJURY OF AN ANOMALOUS VESSEL AND TO IMPROVE THE VISION OF THE WHOLE OPERATING FIELD, UNDERLINING THE POSSIBLE PRESENCE OF ACCESSORY DUCTS, OFTEN RESPONSIBLE OF THE POSTOPERATIVE BILE LOSS OR OF THE CONVERSION IN OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229558 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention