BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9655744 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00685
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 3, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2017. 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: SAFETY AND OUTCOME OF LAPAROSCOPIC SLEEVE GASTRECTOMY FOLLOWING REMOVAL OF ADJUSTABLE GASTRIC BANDING: LESSONS FROM 109 PATIENTS IN A SINGLE CENTER AND REVIEW OF THE LITERATURE. AUTHORS: NIV PENCOVICH1 & GUY LAHAT & ORIT GOLDRAY & SUBHI ABU-ABEID, JOSEPH M. KLAUSNER & SHAI MERON ELDAR. CITATION: OBES SURG. 2017; 27: 1266¿1270. DOI: 10.1007/S11695-016-2463-Y. THE PURPOSE OF THIS STUDY WAS TO RE-ASSESS THE SAFETY AND OUTCOME OF CONVERSION OF FAILED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) TO LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). A TOTAL OF 109 PATIENTS UNDERWENT CONVERSION FROM LAGB TO LSG (78 FEMALE AND 31 MALE PATIENTS; AGE: 43 ± 11.3 YEARS; BMI: 42.4 ± 7.4). DURING THE SURGICAL PROCEDURE, THE SHORT GASTRIC VESSELS WERE TAKEN DOWN ALONG THE GREATER CURVATURE OF THE STOMACH WITH A HARMONIC SCALPEL (ETHICON) OR LIGASURE. ONCE THE BOUGIE TUBE WAS PLACED, SEQUENTIAL FIRINGS OF THE STAPLER (COVIDIEN TRI-STAPLER OR J&J ECHELON), WERE USED TO TRANSECT THE LATERAL STOMACH, CREATING A VERTICAL SLEEVE GASTRECTOMY. REPORTED COMPLICATIONS INCLUDED BLEEDING (N-3) WHICH REQUIRED RE-OPERATION, ANASTOMOTIC LEAK (N-2), INTRA-ABDOMINAL COLLECTION (N-4), HEMATOMA (N-4), AND STENOSIS OF SLEEVE (N-2) WHICH REQUIRED CONVERSION TO GASTRIC BYPASS. THE DATA SUGGESTS THAT CONVERSION OF FAILED LAGB TO LSG IS BOTH SAFE AND EFFECTIVE. A STAGED APPROACH MIGHT BE SAFER, WITH A SMALL SUB-GROUP IN OUR SERIES SHOWING NO COMPLICATIONS WHEN THE SLEEVE WAS PERFORMED SEVERAL MONTHS AFTER EXCISING THE BAND. RANDOMIZED CONTROLLED STUDIES COMPARING CONVERSION OF A FAILED LAGB TO SLEEVE GASTRECTOMY VERSUS OTHER BARIATRIC OPERATIONS ARE NECESSARY TO CLARIFY THE OPTIMAL CONVERSION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113862 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1