BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9604308 · Received January 17, 2020

    Report

    Report Number
    3005075853-2020-00460
    Event Type
    Injury
    Date Received
    January 17, 2020
    Report Date
    December 26, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 1/17/2020. DATE OF EVENT: PUBLICATION YEAR OF 2004. 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: ULTRACISION HARMONIC SCALPEL AND MULTIFUNCTIONAL TEM400 INSTRUMENT COMPLEMENT IN TRANSANAL ENDOSCOPIC MICROSURGERY AUTHOR : I. D. AYODEJI, W. C. J. HOP, G. W. M. TETTEROO, H. J. BONJER, E. J. R. DE GRAAF. CITATION: SURG ENDOSC (2004) 18: 1730¿1737; DOI: 10.1007/S00464-003-9331-2. THIS PROSPECTIVE STUDY DISCUSSED ABOUT THE ULTRACISION HARMONIC SCALPEL (UC) AND MULTIFUNCTIONAL TEM400 INSTRUMENT (T400) COMPLEMENT IN TRANSANAL ENDOSCOPIC MICROSURGERY (TEM). BETWEEN 1996 AND 2002, 196 TUMORS WERE EXCISED IN 184 PATIENTS. THE T400 WAS USED FOR 162 TUMORS T400 (FEMALE=77, MALE=85; MEAN AGE=70 YEARS, AGE RANGE=40-92 YEARS), AND THE UC FOR 34 TUMORS (FEMALE=16, MALE=18; MEAN AGE=68 YEARS, AGE RANGE=35-87 YEARS). ULTRACISION HARMONIC SCALPEL (ETHICON) WAS USED DURING THE PROCEDURE. REPORTED COMPLICATIONS INCLUDED REBLEEDING (N=1); AND ANASTOMOTIC DEHISCENCE (N=1). IN CONCLUSION, THE UC SUBSTANTIALLY REDUCED OPERATIVE TIME COMPARED WITH THE T400, BUT FREQUENTLY REQUIRED THE T400 FOR PROCEDURE COMPLETION. THE T400 IS ALWAYS SINGLY SUFFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63053 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1