BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9554091 · Received January 6, 2020

    Report

    Report Number
    3005075853-2020-00024
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    January 1, 2003
    Report Date
    December 9, 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 OF EVENT: PUBLICATION YEAR OF 2003. 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: EXTENDED ABDOMINOPERINEAL RESECTION WITH PARTIAL PROSTATECTOMY FOR T3 RECTAL CANCER. AUTHOR/S: HIDEYUKI IKE MD, HIROSHI SHIMADA MD, SHOUICHI FUJII MD, NOBUYUKI KAMINUKAI MD, TAKASHI OSHIMA MD TOSHIO IMADA MD. CITATION: HEPATO-GASTROENTEROLOGY 2003; 50: 377-379. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE AND DISCUSS EXTENDED ABDOMINOPERINEAL RESECTION WITH PARTIAL PROSTATECTOMY USING THE ULTRASONIC HARMONIC SCALPEL AS AN ALTERNATIVE TO TOTAL PELVIC EXENTERATION IN LOWER RECTAL T3 CANCER CONTIGUOUS WITH THE PROSTATE. BETWEEN FEB AND MAR 2001, A TOTAL OF 4 MEN WITH LOWER RECTAL T3 CANCER CONTIGUOUS WITH THE PROSTATE WERE TREATED BY EXTENDED ABDOMINOPERINEAL RESECTION WITH PARTIAL PROSTATECTOMY USING ULTRASONIC HARMONIC SCALPEL. THE LEVATOR ANI MUSCLE CAN BE DIVIDED SAFELY BY THE ULTRASONIC HARMONIC SCALPEL (ETHICON). AFTER WITHDRAWING THE RECTUM, THE POSTERIOR PART OF THE PROSTATE THAT WAS CONTIGUOUS WITH THE RECTAL CANCER WAS DIVIDED EN BLOC USING ULTRASONIC HARMONIC SCALPEL WITHOUT MASSIVE BLEEDING. A (B)(6) MAN HAD 890 ML BLOOD LOSS THAT DID NOT REQUIRE BLOOD TRANSFUSION; HAD A "URETHERAL" INJURY THAT WAS MANAGE CONSERVATIVELY USING AN INDWELLING URINARY CATHETER FOR 3 MONTHS; AND HAD A URINARY DYSFUNCTION. A (B)(6) MAN HAD 2500 ML BLOOD LOSS THAT REQUIRED BLOOD TRANSFUSION. A (B)(6) MAN HAD 1300 ML BLOOD LOSS THAT DID NOT REQUIRE BLOOD TRANSFUSION; AND HAD URINARY DYSFUNCTION. A (B)(6) MAN HAD 600 ML BLOOD LOSS THAT DID NOT REQUIRE BLOOD TRANSFUSION. EXTENDED ABDOMINOPERINEAL RESECTION WITH PARTIAL PROSTATECTOMY USING THE ULTRASONIC HARMONIC SCALPEL IS AN ATTRACTIVE ALTERNATIVE TO TOTAL PELVIC EXENTERATION FOR PATIENTS WITH LOWER RECTAL T3 CANCER CONTIGUOUS WITH THE PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13439 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1