BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9508550 · Received December 21, 2019

    Report

    Report Number
    3005075853-2019-24721
    Event Type
    Injury
    Date Received
    December 21, 2019
    Report Date
    November 28, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/21/2019. PUBLICATION YEAR OF 2019. 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: HAND-ASSISTED LAPAROSCOPIC RESTORATIVE PROCTOCOLECTOMY FOR ULCERATIVE COLITIS: THE OPTIMIZATION OF INSTRUMENTATION TOWARD STANDARDIZATION. AUTHORS: KIYOKAZU NAKAJIMA, RIICHIRO NEZU, TOSHINORI ITO, AND TOSHIROU NISHIDA CITATION: SURG TODAY (2010) 40:840¿844, DOI 10.1007/S00595-009-4157-8. THE STUDY WAS CONDUCTED RETROSPECTIVELY USING A PROSPECTIVELY COMPILED SURGICAL DATABASE AND AIMED TO REVIEW THE OPTIMIZATION OF THE INSTRUMENTATION FOR HAND-ASSISTED LAPAROSCOPIC SURGERY FOR RESTORATIVE PROCTOCOLECTOMY (HALS-RP) AND DISCUSSES THEIR IMPACT ON SURGICAL/EARLY POSTOPERATIVE OUTCOMES. BETWEEN JULY 1998 AND FEBRUARY 2006, A TOTAL OF 66 PATIENTS (N=35 MALES AND 31 FEMALES, AGE RANGE: 13-73 YEARS) WITH ULCERATIVE COLITIS WERE INCLUDED IN THE STUDY. THE CASES WERE DIVIDED INTO SUBGROUPS ACCORDING TO (1) HAND-ACCESS DEVICES AND (2) VASCULAR CONTROL DEVICES. THE PATIENTS WERE DIVIDED INTO TWO SUBGROUPS ACCORDING TO THE VASCULAR CONTROL DEVICES USED AT THE TIME OF MESENTERIC DIVISION DURING HALS-RP. LAPAROSONIC COAGULATING SHEARS (HARMONIC SCALPEL) (ETHICON) WITH CLIPS WERE USED IN THE FIRST 29 PATIENTS (LCS GROUP). THE COLONIC MESENTERY WAS DIVIDED WITH ELECTROSURGICAL VESSEL SEALING INSTRUMENTS WITHOUT CLIPS IN THE REMAINING 37 PATIENTS (LIGASURE GROUP). COMPLAINTS INCLUDED BOWEL INJURY (N=1), LEAKAGE (N=1), BLOOD LOSS (N=9) NEEDING TRANSFUSIONS, AND POSTOPERATIVE BLEEDING FROM THE ILEAL POUCH (N=3). IN CONCLUSION, THE COMBINATION USE OF SUITABLE SURGICAL DEVICES CONTRIBUTED TO THE IMPROVED OUTCOME OF HALS-RP. WITH THE POSITIVE ADOPTION OF THESE EVOLVING TECHNOLOGIES, HALS-RP IS THEREFORE EXPECTED TO BECOME A MORE COMFORTABLE AND STANDARDIZED PROCEDURE FOR UC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303016 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention