BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9478739 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24433
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2013. 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 OF ULTRASONIC DISSECTION VERSUS CONVENTIONAL ELECTROCAUTERY DISSECTION DURING LAPAROSCOPIC CHOLECYSTECTOMY IN TERMS OF GALL BLADDER PERFORATION AUTHORS: NADIM KHAN, MUNIR AHMAD, ZAHOOR AHMAD, AMJAD KHAN, MUZAFAR-UDDIN SADIQ CITATION: J POSTGRAD MED INST 2013; 27(2):157-63. THIS RANDOMIZED CONTROLLED TRIAL AIMED TO COMPARE THE SAFETY OF ULTRASONIC AND ELECTROCAUTERY METHOD OF DISSECTION IN TERMS OF GALL BLADDER PERFORATION. FROM NOVEMBER 2011 TO MAY 2012, 128 PATIENTS WITH SYMPTOMATIC GALL STONE DISEASE WERE RANDOMLY ALLOCATED INTO TWO GROUPS. IN GROUP A (N=64) (MEAN AGE 37.28±14.4 YEARS, MALE N=19 AND FEMALE N=45), THE METHOD OF DISSECTION WAS BY ULTRASONIC DEVICE (HARMONIC) WHEREAS IN GROUP B (N=64) (MEAN AGE 35.98±13.29, MALE N=20 AND FEMALE N=44), CONVENTIONAL MONOPOLAR ELECTROCAUTERY METHOD OF DISSECTION WAS USED FOR DISSECTION OF THE GALL BLADDER FROM ITS BED. COMPLICATIONS IN GROUP A (HARMONIC ULTRASONIC DEVICE) INCLUDED GALL BLADDER PERFORATION (N=7). IN CONCLUSION, ULTRASONIC DISSECTION IS SAFER MODALITY OF DISSECTION IN TERMS OF GALL BLADDER PERFORATION AND ITS USE SHOULD BE ENCOURAGED AS ROUTINE METHOD OF DISSECTION DURING LC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275744 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention