BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9475781 · Received December 16, 2019

    Report

    Report Number
    3005075853-2019-24378
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    January 1, 2011
    Report Date
    November 19, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2011. 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: CIRCUMFERENTIAL SUPERFICIAL FASCIA LIFT OF THE LOWER TRUNK: SURGICAL TECHNIQUE AND RETROSPECTIVE REVIEW OF 50 CASES. AUTHOR/S: MATTHIAS KOLLER, THOMAS HINTRINGER. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2012) 65, 433-438; DOI:1016/J.BJPS.2011.09.045. THIS RETROSPECTIVE REVIEW AIMED TO PRESENT RESULTS OF 50 CASES OF CIRCUMFERENTIAL SUPERFICIAL FASCIA LIFT OF THE LOWER TRUNK. BETWEEN NOV2008 AND APR2010, A TOTAL OF 50 PATIENTS (N=9 MALE AND N=41 FEMALE; MEAN AGE OF 40 YEARS [RANGED 22-63 YEARS]; AVERAGE WEIGHT WAS 74 KG AND AVERAGE BMI WAS 27.9) WERE SCHEDULED FOR CIRCUMFERENTIAL SUPERFICIAL FASCIA LIFTING OF THE LOWER TRUNK. IN THE PROCEDURE, WE INCISE THE SUPERIOR RESECTION LINE DOWN TO THE LEVEL OF SUPERFICIAL FASCIA WITH THE KNIFE AND ELEVATE THE SKIN FLAP USING THE HARMONIC SCALPEL. COMPLICATIONS INCLUDED SECONDARY BLEEDING (N=1) NEEDING REVISION THE FIRST DAY AFTER THE OPERATION; AND POSTOPERATIVE SEROMA FORMATION (N=4) THAT WAS TREATED WITH ONE TO THREE PUNCTURES IN THE AMBULATORY SETTING. MORE SUPERFICIAL PREPARATION IN ABDOMINOPLASTY FLAP ELEVATION BECAME AN ISSUE BECAUSE OF SEROMA FORMATION BEING THE MOST FREQUENT COMPLICATION. MINOR POSTOPERATIVE FLUID COLLECTION FOLLOWING MORE SUPERFICIAL PREPARATION 4,5 HAS BEEN REPORTED IN SEVERAL STUDIES. THE MECHANISM IS STILL NOT CLEAR AND NEEDS FURTHER INVESTIGATION. MINOR LYMPHATIC VESSEL HARVEST IS PLAUSIBLE BUT LACKING EVIDENCE. IN THIS PATIENT COHORT, WE PERFORMED MORE SUPERFICIAL FLAP ELEVATION WITH THE ULTRASONICALLY ACTIVATED SCALPEL. WE COMPARED TWO DIFFERENT TOOLS THAT SHOULD LEAD TO MINOR SEROMA FORMATION. ACCORDING TO OUR LOW RATE OF COMPLICATIONS, THIS COMBINATION SEEMS TO BE BENEFICIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271622 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention