BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9461020 · Received December 12, 2019

    Report

    Report Number
    3005075853-2019-24227
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    November 13, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATE OF EVENT: PUBLICATION YEAR OF 2014. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: OUTCOME ANALYSIS OF LAPAROSCOPIC D1 AND D2 DISSECTION IN PATIENTS 70 YEARS AND OLDER WITH GASTRIC CANCER. AUTHOR/S: SEYFI EMIR1, SELIM SÖZEN1, ILHAN BALI1, SIBEL ÖZKAN GÜRDAL1, BÜNYAMIN CÜNEYT TURAN2, OGUZHAN YILDIRIM3, TARKAN YETISYIGIT. CITATION: INT J CLIN EXP MED 2014;7(10):3501-3511. THE PURPOSE THIS RETROSPECTIVE STUDY WAS TO COMPARE THE POSTOPERATIVE MORBIDITY AND MORTALITY RATES OF PATIENTS AGED OVER 70 WITH GASTRIC CANCER WHO UNDERWENT LAPAROSCOPIC D1 AND D2 LYMPH NODE DISSECTION (LND) AND TO ASSESS THE FACTORS AFFECTING MORBIDITY AND MORTALITY AS WELL AS SURVIVAL. D1 RESECTION (LEVEL1 LYMPHADENECTOMY) WAS COMPARED WITH D2 RESECTION (LEVELS 1 AND 2 LYMPHADENECTOMY). BETWEEN MARCH 2008 AND OCTOBER 2010, A TOTAL OF 53 PATIENTS WERE INCLUDED IN THE STUDY. OF THE PATIENTS, 28 PATIENTS (MALE=17, FEMALE=11) UNDERWENT TO D1 LND AND 25 PATIENTS (MALE=14, FEMALE=11) UNDERWENT D2 LND. DURING THE LAPAROSCOPIC DISTAL SUBTOTAL GASTRECTOMY [D1 GROUP (N=13), D2 GROUP (N=11)], THE VESSELS WERE CAREFULLY PREPARED AND SEPARATELY DIVIDED, USING HARMONIC SCISSORS (ETHICON) IN THE VEIN AND USING ENDOSTAPLER IN THE ARTERY. DURING LAPAROSCOPIC TOTAL GASTRECTOMY [D1 GROUP (N=15), D2 GROUP (N=14)], THE GREATER OMENTUM WAS FIRST DISSECTED, USING THE ULTRASONIC ACTIVATED SCISSORS (ULTRACISION-HARMONIC SCALPEL; ETHICON), ALONG THE BORDER OF THE TRANSVERSE COLON. THE ESOPHAGUS WAS DIVIDED WITH THE ULTRASONIC SCISSOR APPROXIMATELY 2 CM ABOVE THE GASTROESOPHAGEAL JUNCTION. REPORTED COMPLICATIONS IN D1 LND GROUP INCLUDED MEAN BLOOD LOSS 235.6 ± 125.0 ML (N=28), IN WHICH 22 PATIENTS NEEDED TRANSFUSION; PANCREATIC FISTULA (N=1); ABDOMINAL ABSCESS (N=1); AND FLUID COLLECTION (N=1). REPORTED COMPLICATIONS IN D2 LND GROUP INCLUDED MEAN BLOOD LOSS 400.6 ± 220.5 ML (N=28), IN WHICH PATIENTS NEEDED TRANSFUSION; PANCREATIC FISTULA (N=2); ABDOMINAL ABSCESS (N=1); AND FLUID COLLECTION (N=2). IN CONCLUSION, AMONG PATIENTS AGED OVER 70 YEARS WITH GASTRIC CANCER, THE MORBIDITY AND MORTALITY RATES IN PATIENTS WHO UNDERWENT D2 LND WERE SIMILAR TO THOSE IN PATIENTS WHO HAD D1 LND. D2 LND PROLONGS THE OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257746 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention