BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9470630 · Received December 14, 2019

    Report

    Report Number
    3005075853-2019-24337
    Event Type
    Injury
    Date Received
    December 14, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: COMPARISON OF ULTRASONIC SHEARS AND TRADITIONAL SUTURE LIGATURE FOR VAGINAL HYSTERECTOMY: RANDOMIZED CONTROLLED TRIAL. AUTHOR(S): ALISON LOUISE FITZ-GERALD, MBBS; JASON TAN, MBBS, FRANZCOG, CGO; KOK-WENG CHAN, MBBS, FRANZCOG; ALEX POLYAKOV, MBBS, FRANZCOG, MCLINEPID, MREPROMED, GRADCERTEBM; GEOFF N. EDWARDS, MBBS, FRCOG, FRANZCOG, DDU; HAIDER NAJJAR, MBCHB, FRANZCOG; JIM TSALTAS, MBBS, FRANZCOG, FRCOG; AND BEVERLEY VOLLENHOVEN, MBBS(HONS), PHD, FRANZCOG, CREI. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2013) 20, 853¿857 / HTTP://DX.DOI.ORG/10.1016/J.JMIG.2013.05.019. THE PURPOSE OF THIS RANDOMIZED CONTROLLED TRIAL WAS TO DETERMINE WHETHER ULTRASONICALLY ACTIVATED SHEARS (USS), WHEN USED TO PERFORM VAGINAL HYSTERECTOMY, CAN REDUCE OPERATING TIME, INTRAOPERATIVE BLOOD LOSS, NEED FOR POSTOPERATIVE ANALGESIA, AND DURATION OF HOSPITAL STAY. BETWEEN SEP 2007 AND JUNE 2009, A TOTAL OF 40 WOMEN WITH BENIGN DISEASE UNDERWENT VAGINAL HYSTERECTOMY. PATIENTS WERE RANDOMLY ASSIGNED TO 1 OF 2 TECHNIQUES: THE ULTRASONIC SYSTEM (USS) GROUP [N=21, MEAN AGE 57.24 YEARS (2.68 YEARS), MEAN WEIGHT 75.81 KG (4.01 KG)] AND TRADITIONAL SUTURE GROUP [N=19, MEAN AGE 58.26 YEARS (2.56 YEARS), MEAN WEIGHT 72.95 KG (3.59 KG)]. IN THE USS GROUP, ALL PEDICLES, REGARDLESS OF SIZE, WERE SEALED USING THE USS HARMONIC SCALPEL (ETHICON ENDO-SURGERY). IN THE TRADITIONAL ARM, ALL PEDICLES WERE CLAMPED, CUT, AND LIGATED USING POLYGLACTIN 910 (VICRYL) SUTURES. INTRAOPERATIVE COMPLICATION INCLUDED FAILED PEDICLE HEMOSTASIS (N=2) WHICH WERE SUBSEQUENTLY SECURED USING POLYGLACTIN SUTURES. POSTOPERATIVE COMPLICATIONS INCLUDE PAIN [N=15 (N=8 USS GROUP, N=7 TRADITIONAL GROUP)], WHEREIN 3 PATIENTS FROM USS GROUP AND 2 PATIENT FROM TRADITIONAL GROUP RECEIVED MORPHINE CONTROLLED-ANALGESIC INFUSIONS, RESPECTIVELY; AND FAILED ATTEMPT TO VOID (N=9) WHEREIN BEFORE DISCHARGE, ALL PATIENTS IN THE USS GROUP PASSED SUBSEQUENT TRIALS OF VOIDING. ALTHOUGH COMPARED WITH TRADITIONAL SUTURE LIGATION, THE HARMONIC SCALPEL SYSTEM SEEMS TO BE A SAFE ALTERNATIVE FOR SECURING THE PEDICLES IN VAGINAL HYSTERECTOMY, IT OFFERS NO BENEFIT INSOFAR AS DURATION OF OPERATION, REDUCTION IN CLINICALLY SIGNIFICANT BLOOD LOSS, AND ANALGESIC REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265325 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other