BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9350334 · Received November 20, 2019

    Report

    Report Number
    3005075853-2019-23617
    Event Type
    Injury
    Date Received
    November 20, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    TITLE : LAPAROSCOPIC VERSUS OPEN LIVER SURGERY: A SINGLE CENTER ANALYSIS OF POST-OPERATIVE IN-HOSPITAL AND POST-DISCHARGE RESULTS. AUTHOR : ABDALLAH SLIM & MATTIA GARANCINI & STEFANO DI SANDRO & IACOPO MANGONI & ANDREA LAUTERIO & ALESSANDRO GIACOMONI & LUCIANO DE CARLIS S. NAVARRO-SOTO. CITATION: LANGENBECKS ARCH SURG (2012); 397:1305¿1311. DOI: 10.1007/S00423-012-0992-Y. THE AIM OF THIS RETROSPECTIVE ANALYSIS WAS TO COMPARE A COHORT OF PATIENTS WHO HAVE UNDERGONE LAPAROSCOPIC HEPATECTOMY (LH) WITH A MATCHED-PAIR GROUP OF PATIENTS WHO HAVE UNDERGONE OPEN HEPATECTOMY (OH) IN TERMS OF SHORT-TERM AND LONGER TERM POSTOPERATIVE OUTCOMES, IN ORDER TO ASSESS THE POTENTIAL BENEFITS OF LH. FORTY-SIX PATIENTS (21 MALE AND 25 FEMALE; MEDIAN AGE: 59) WHO HAVE UNDERGONE LH FROM SEPTEMBER 2008 TO SEPTEMBER 2011 (LH GROUP) WERE COMPARED TO 46 MATCHED-PAIR CONTROL PATIENTS (20 MALE AND 26 FEMALE; MEDIAN AGE: 65) WHO HAVE UNDERGONE OH (OH GROUP). FOR LH, THE PARENCHYMAL TRANSECTION WAS PERFORMED USING ULTRACISION (ETHICON) PLUS BIPOLAR SHEARS. REPORTED COMPLICATION IN THE LH GROUP INCLUDED ABDOMINAL COLLECTION/ABSCESSES (N-1) IN WHICH THE PATIENT WAS READMITTED. IN CONCLUSION, PATIENTS WHO HAVE UNDERGONE LH SHOW BETTER SHORT-TERM POST-OPERATIVE OUTCOMES AND REQUIRE SIGNIFICANTLY LESS POST-DISCHARGE OUTPATIENT CLINIC APPOINTMENTS (OCA) AND HOSPITAL READMISSIONS (RA). THE RESULTS INDICATE THAT BENEFITS RELATED TO LH ARE CONFIRMED EVEN AFTER THE IMMEDIATE POST-OPERATIVE PERIOD, SUGGESTING POTENTIAL BETTER PATIENT'S SATISFACTION AND LOWER HOSPITAL COST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140421 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention