BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9470616 · Received December 14, 2019

    Report

    Report Number
    3005075853-2019-24323
    Event Type
    Injury
    Date Received
    December 14, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2001. 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: THE USE OF THE HARMONIC SCALPEL TO REDUCE MORBIDITY DURING OPEN TOTAL ABDOMINAL HYSTERECTOMIES WITH BILATERAL SALPINGOOOPHORECTOMY (TAH/BSO). AUTHOR : KAREN GRASSIE, MD, AND MICHAEL MAKII, MD. CITATION: CURRENT SURGERY VOLUME 58, NUMBER 3, MAY/JUNE 2001. THIS STUDY IS A NONRANDOMIZED, PROSPECTIVE STUDY THAT IS DESIGNED TO COMPARE AN ULTRASONIC SCALPEL (USS) (ETHICON) DISSECTION WITH THE STANDARD APPROACH IN AN OPEN HYSTERECTOMY IN TERMS OF THE AMOUNT OF INTRAOPERATIVE BLOOD LOSS, TIME, AND COST, AS WELL AS POSTOPERATIVE LENGTH OF STAY AND INCIDENCE OF COMPLICATIONS. A TOTAL OF 38 TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (TAHBSO) WERE PERFORMED BY THE SAME SURGEON OVER A 7-MONTH PERIOD FOR BENIGN OR MALIGNANT DISEASE. OUT OF 38 PATIENTS, 16 CASES OF TAHBSO DONE THROUGH THE USS (MEAN AGE: 60 YEARS, RANGE: 27-77 YEARS, MEAN WEIGHT: 77 KG WITH RANGE OF 49-111 KG), AND 21 CASES DONE THROUGH THE TRADITIONAL METHODS OF DISSECTION AND LIGATION. THE USS WAS USED FOR THE COAGULATIVE CUTTING OF THE VAGINAL CUFF AS WELL AS FOR THE PEDICLES AND LIGAMENTS ATTACHED TO THE UTERUS AND ADNEXA. COMPLAINTS INCLUDED ESTIMATED BLOOD LOSS OF 362.5 ML (RANGE: 100-1300) (N=16), AND POSTOPERATIVE ILEUS (N=1). THE RESULTS OF THE STUDY SHOWED A STATISTICALLY SIGNIFICANT REDUCTION OCCURRED IN ESTIMATED BLOOD LOSS WITH THE USE OF THE USS. THERE IS ALSO DECREASED INTRAOPERATIVE TIME, AS WELL AS DECREASED POSTOPERATIVE COMPLICATIONS AND LENGTH OF STAY IN THIS SAME GROUP; HOWEVER, THESE DIFFERENCES WERE NOT STATISTICALLY SIGNIFICANT. ALSO, MORE COMPLICATIONS ARE REPORTED IN THE TRADITIONAL RESECTION GROUP. IT WOULD BE BENEFICIAL TO ACCRUE A HIGHER PATIENT POPULATION AND STUDY THE USE OF THE USS IN THIS PROCEDURE AS WELL AS OTHER OPEN ABDOMINAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265269 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention