BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9465383 · Received December 13, 2019

    Report

    Report Number
    3005075853-2019-24251
    Event Type
    Injury
    Date Received
    December 13, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2005. 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: SAFETY OF ONE-STAGE RESTORATIVE PROCTOCOLECTOMY FOR ULCERATIVE COLITIS AUTHORS: HIROKI IKEUCHI, M.D., HIROKI NAKANO, M.D., MOTOI UCHINO, M.D., MITSUHIRO NAKAMURA, M.D., MASAFUMI NODA, M.D., HIDENORI YANAGI, M.D., TAKEHIRA YAMAMURA, M.D. CITATION: DIS COLON RECTUM 2005; 48: 1550¿1555; DOI: 10.1007/S10350-005-0083-Z. THE AIM OF THIS STUDY WAS TO COMPARE POSTOPERATIVE COMPLICATIONS AND OUTCOMES AFTER RESTORATIVE PROCTOCOLECTOMY (RPC) WITH MUCOSECTOMY BY USE OF THE HARMONIC SCALPEL BETWEEN PATIENTS WITH ULCERATIVE COLITIS (UC) WHO HAD AND DID NOT HAVE DIVERTING ILEOSTOMY. FROM NOVEMBER 1999 TO AUGUST 2003, A SERIES OF 242 CONSECUTIVE PATIENTS (N=150 WITHOUT ILEOSTOMY [N=72 MALES N=78 FEMALES, MEDIAN AGE: 30 YEARS, AGE RANGE: 15-69]; N=92 WITH ILEOSTOMY [N=47 MALES N=45 FEMALES, MEDIAN AGE: 35.5 YEARS, AGE RANGE: 15-68]) WERE INCLUDED IN THE STUDY. AN ULTRASONICALLY ACTIVATED SCALPEL (HARMONIC SCALPEL® (HS); ETHICON) WAS USED DURING TRANS-ANAL MUCOSECTOMY WHICH REQUIRED CAVITATIONAL CUTTING AND TISSUE PLANE SEPARATION WITHOUT INJURING THE REMAINING SPHINCTERS. COMPLAINT INCLUDED PERIANAL WOUND INFECTION (N=5 IN GROUP WITHOUT ILEOSTOMY). THE DATA IN THIS STUDY PRESENTED THAT RESTORATIVE PROCTOCOLECTOMY WITH MUCOSECTOMY BY USE OF AN ULTRASONICALLY ACTIVATED SCALPEL AND WITHOUT DIVERSION IS A SUPERIOR THERAPEUTIC CHOICE FOR SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264653 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other