BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9478659 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24426
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2019. 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 : MINIMAL INVASIVE LAPAROSCOPIC HYSTERECTOMY WITH ULTRASONIC SCALPEL. AUTHOR : THOMAS GYR, M.D., FABIO GHEZZI, M.D.,*, SEMIR ARSLANAGIC, M.D., LINDA LEIDI, M.D. GIANNI PASTORELLI, M.D., MASSIMO FRANCHI, M.D. CITATION: THE AMERICAN JOURNAL OF SURGERY 181 (2001) 516¿519. THE PURPOSE OF THIS STUDY WAS TO EVALUATE IF TOTAL LAPAROSCOPIC HYSTERECTOMY USING THE ULTRASONIC SCALPEL IS FEASIBLE AND WHETHER THIS PROCEDURE OFFERS ADVANTAGES IN COMPARISON WITH ABDOMINAL HYSTERECTOMY IN THE SETTING OF A REGIONAL HOSPITAL. THIS CASE-CONTROL STUDY INVOLVES 144 FEMALE PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY AND ABDOMINAL HYSTERECTOMY FOR BENIGN CONDITIONS. IN TLH GROUP, 48 FEMALE PATIENTS (AGE: 50.4¿ 8.2 YEARS) UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY WITH ULTRASONIC SCALPEL (ETHICON) AND IN TAH GROUP, 96 FEMALE PATIENTS (AGE: 51.0¿ 9.8 YEARS) UNDERWENT ABDOMINAL HYSTERECTOMY. DURING THE PROCEDURE FOR THE TOTAL LAPAROSCOPIC HYSTERECTOMY, THE ROUND LIGAMENT WERE DESICCATED AND DIVIDED. IF THE ADNEXA WERE TO BE REMOVED, THE TUBO-OVARIAN PEDICLES WERE COAGULATED AND TRANSACTED ON BOTH SIDES, WHILE IF THE ADNEXA WERE TO BE CONSERVED THE UTERO-OVARIAN PEDICLES WERE COAGULATED AND TRANSECTED. THE UTEROVESICAL PERITONEUM WAS INCISED. THE UTERINE ARTERIES WERE IDENTIFIED AND TRANSECTED. THE UTEROSACRAL LIGAMENTS WERE DISSECTED AND COLPOTOMY WAS PERFORMED AT THE RIM OF THE CERVICAL CUP. ALL THESE STEPS WERE DONE USING THE ULTRASONIC SCALPEL (ULTRACISION; ETHICON). THE VAGINAL VAULT WAS CLOSED TRANSVAGINALLY WITH THREE INTERRUPTED 0 POLYGLACTIN 910 SUTURES (VICRYL; ETHICON) INCORPORATING THE VAGINAL ANGLES AND THE CENTRAL VAGINA. REPORTED COMPLICATION IN THE TLH GROUP INCLUDED INCIDENTAL BLADDER INJURY/URINARY TRACT INJURY IN A PATIENT WITH A UTERUS OF 1,080G (N-1) WHICH WAS REPAIRED LAPAROSCOPICALLY WITH A CONTINUOUS ABSORBABLE SUTURE WITHOUT FURTHER COMPLICATION, AND ESTIMATED BLOOD LOSS (ML) 80 (RANGE: 10 ¿ 1,000) (N-?). TOTAL LAPAROSCOPIC HYSTERECTOMY WITH THE ULTRASONIC SCALPEL IS FEASIBLE AND SAFE, AND OFFERS NOT ONLY COSMETIC BENEFITS BUT ALSO REDUCES THE NEED OF ANALGESIA AND THE TIME TO RETURN TO A NORMAL GASTROINTESTINAL FUNCTION IN COMPARISON WITH THE CONVENTIONAL ABDOMINAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272629 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other