BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9364514 · Received November 22, 2019

    Report

    Report Number
    3005075853-2019-23721
    Event Type
    Injury
    Date Received
    November 22, 2019
    Report Date
    October 28, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 11/22/2019. BATCH # UNK. FOLLOWING INFORMATION REQUESTED BUT UNAVAILABLE: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: CONCURRENT LEARNING CURVES OF 3-DIMENSIONAL AND ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL HYSTERECTOMY FOR EARLY-STAGE CERVICAL CANCER USING 2-DIMENSIONAL LAPAROSCOPIC RADICAL HYSTERECTOMY AS A BENCHMARK: A SINGLE SURGEON¿S EXPERIENCE AUTHOR/S: XISHI LIU, SUN-WEI GUO, DING DING, HONGYUAN JIANG, JICHAN NIE. CITATION: DING D. ET AL.: 3-DIMENSIONAL AND ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL HYSTERECTOMY © MED SCI MONIT, 2019; 25: 5903-5919 , DOI: 10.12659/MSM.914952. THE OBJECTIVE OF THIS PROSPECTIVE STUDY IS TO ASSESS AND COMPARE THE LEARNING CURVES OF 3-DIMENSIONAL LAPAROSCOPIC RH (3D-LRH) AND ROBOTIC-ASSISTED (RA)-LRH PROCEDURES AND TO COMPARE INTRA-, PERI-, AND POSTOPERATIVE OUTCOMES OF 3D AND RA PROCEDURES BY A SURGEON HIGHLY SKILLED IN 2-DIMENSIONAL (2D)-LRH FOR TREATMENT OF EARLY-STAGE CERVICAL CANCER. TWO HUNDRED AND THIRTY-NINE (239) FEMALE PATIENTS WITH EARLY-STAGE CERVICAL CANCER (FIGO STAGE: IA2¿IIA2) ADMITTED TO SHANGHAI OBSTETRICS AND GYNECOLOGY HOSPITAL, (B)(6) UNIVERSITY WERE INVOLVED IN THE STUDY: 54, 85, AND 100 PATIENTS UNDERWENT 2D-, 3D-, AND RA-LRH, RESPECTIVELY. ALL CASES WERE PERFORMED BY THE SAME SURGEON (XSL) IN FEBRUARY 2015 THROUGH JUNE 2016. PATIENTS¿ AGES RANGED 29-64 YEARS FOR 2D-LRH, 29-67 YEARS FOR 3D-LRH, AND 28- 66 YEARS FOR RA-LRH. THE PATIENTS¿ BODY MASS INDEX (BMI) MEDIAN RANGES WERE 21.6 FOR 2D-LRH, 21.4 FOR 3D-LRH, AND 22.3 FOR RA-LRH. FOR 2D- AND 3D-LRH, THE MAJOR ENERGY DEVICE USED WAS A HARMONIC ACE® (ETHICON ENDO-SURGERY, CINCINNATI, OH, USA). THE PERITONEUM FROM THE SURFACE UNDERNEATH THE BLADDER WAS SEWN TO THE SURFACE OF THE RECTUM WITH 0 MONOCRYL SUTURES. IN CASE OF OVARIAN PRESERVATION, THE OVARIES WERE TRANSPOSED TO THE ABDOMINAL SIDEWALL UP OUT OF THE PELVIS USING 0-VICRYL SUTURE ON A CT-1 NEEDLE. POST-OPERATIVE HEMORRHAGE WAS FOUND IN 1 PATIENT (9.1%) IN THE 3D-LRH GROUP, DUE TO DIFFUSIVE BLEEDING AT THE CARDINAL LIGAMENT, WHICH WAS REMEDIED BY A SECOND LAPAROSCOPIC SURGERY. THE MEDIAN RANGE OF THE AMOUNT OF BLOOD LOSS (ML) WAS 200 (30¿700) FOR 2D-LRH, 200 (20¿1500) FOR 3D-LRH, AND 200 (100¿1300) FOR RA-LRH. TWO (2) PATIENTS FROM THE 2D-LRH, 3 PATIENTS FROM 3D-LRH, AND 11 FROM RA-LRH UNDERWENT BLOOD TRANSFUSION. IN CONCLUSION, THE AUTHORS REPORTED THAT THE 3D-LRH WAS SUPERIOR TO 2D-LRH AND RA-LRH IN TERMS OF SIGNIFICANTLY SHORTER OT AND SLIGHTLY LESS BLOOD LOSS THAN RA-LRH. MASTERING 3D- OR RA-LRH HAD A STEEP LEARNING CURVE FOR AN EXPERIENCED SURGEON WITH AN EXCELLENT COMMAND OF 2D LAPAROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159732 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention