BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9377529 · Received November 26, 2019

    Report

    Report Number
    3005075853-2019-23782
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    January 1, 2005
    Report Date
    November 6, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN. THEREFORE, THE 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCT: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DATE SENT: 11/25/2019. DATE OF EVENT: PUBLICATION YEAR OF 2005. 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. (B)(4).

    Description of Event or Problem · 1

    TITLE: RANDOMIZED CLINICAL TRIAL OF TRADITIONAL DISSECTION WITH ELECTROCAUTERY VERSUS ULTRASONIC FUNDUS-FIRST DISSECTION IN LAPAROSCOPIC CHOLECYSTECTOMY. AUTHOR : Y. CENGIZ, A. JANES, A° . GREHN AND L. A. ISRAELSSON. CITATION: BRITISH JOURNAL OF SURGERY. 2005; 92: 810¿813. DOI: 10.1002/BJS.4982. IN LAPAROSCOPIC CHOLECYSTECTOMY, DISSECTION CAN BE WITH MONOPOLAR ELECTROCAUTERY OR WITH ULTRASONIC SHEARS, AND CAN START AT THE TRIANGLE OF CALOT OR AT THE FUNDUS OF THE GALLBLADDER. A TOTAL OF 37 PATIENTS (AGE RANGE: 43 TO 50 YEARS OLD; 7 MALE AND 30 FEMALE PATIENTS; BMI: 25 TO 28) UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY WERE RANDOMIZED TO ELECTROCAUTERY DISSECTION FROM THE TRIANGLE OF CALOT AND 43 PATIENTS (AGE RANGE: 40 TO 47 YEARS OLD; 13 MALE AND 30 FEMALE PATIENTS; BMI: 26 TO 29) TO FUNDUS-FIRST DISSECTION WITH ULTRASONIC SHEARS. WITH THE FUNDUS-FIRST TECHNIQUE, ULTRACISION HARMONIC SHEARS (ETHICON) WERE USED. THE CYSTIC ARTERY WAS DIVIDED WITH THE ULTRACISION HARMONIC SHEARS (ETHICON) AND THE CYSTIC DUCT WAS AGAIN CLIPPED. IN THE FUNDUS-FIRST TECHNIQUE GROUP, REPORTED COMPLICATIONS INCLUDED PAIN (N-?) AND WOUND INFECTION (N-1). AMBULATORY LAPAROSCOPIC CHOLECYSTECTOMY WAS PERFORMED MORE QUICKLY BY ULTRASONIC FUNDUS-FIRST DISSECTION THAN BY ELECTROCAUTERY DISSECTION STARTING AT THE TRIANGLE OF CALOT. THIS DIFFERENCE WAS MORE PRONOUNCED WHEN CHOLECYSTITIS WAS PRESENT. IT WAS CONCLUDED THAT THE ULTRASONIC FUNDUS-FIRST DISSECTION DURING LAPAROSCOPIC CHOLECYSTECTOMY WAS QUICKER AND ASSOCIATED WITH LESS NAUSEA AND PAIN THAN ELECTROCAUTERY DISSECTION FROM THE TRIANGLE OF CALOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169602 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention