BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9511141 · Received December 23, 2019

    Report

    Report Number
    3005075853-2019-24736
    Event Type
    Injury
    Date Received
    December 23, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/23/2019. BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR FOR THE JOURNAL ARTICLE IS 2011. 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

    IT WAS REPORTED THAT DURING A REVIEW OF A JOURNAL ARTICLE, TITLE: THE OUTCOME OF LAPAROSCOPIC RADICAL HYSTERECTOMY (LRH) AND PELVIC LYMPHADENECTOMY IN PATIENTS WITH EARLY INVASIVE CERVICAL CANCER. AUTHOR/S: JIHAD D.; FRITZ J. CITATION: GYNECOL SURG (2011) 8 (SUPPL 1):S185. DOI 10.1007/S10397-011-0694-4. THE AIM OF THIS STUDY WAS TO EVALUATE RETROSPECTIVELY FEASIBILITY AND ONCOLOGICAL OUTCOME OF LAPAROSCOPIC RADICAL HYSTERECTOMY (LRH) IN PATIENTS WITH IB1 STAGE CERVICAL CANCER. THIS RETROSPECTIVE STUDY INVOLVES 50 PATIENTS WITH CERVICAL CANCER (STAGE IB1) AND WERE TREATED WITH LRH AND PELVIC LYMPHADENECTOMY. THE RADICAL HYSTERECTOMY WAS PERFORMED USING THE HARMONIC SCALPEL (ETHICON). REPORTED COMPLICATION INCLUDED POSTOPERATIVE BLEEDING (N-1) WHICH NEEDED A SECOND SURGERY, AND URETEROVAGINAL FISTULA AFTER THE OPERATION (N-1). IN CONCLUSION, THE LRH IS FEASIBLE WITH EXCELLENT SURGICAL AND ONCOLOGICAL OUTCOME WHICH IS COMPARABLE TO PATIENTS TREATED WITH LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304416 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention