BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9508547 · Received December 21, 2019

    Report

    Report Number
    3005075853-2019-24632
    Event Type
    Injury
    Date Received
    December 21, 2019
    Date of Event
    January 1, 2008
    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 Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2008. MEDICAL DEVICE: 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: GENITOFEMORAL NERVE INJURY AFTER LAPAROSCOPIC VARICOCELECTOMY IN ADOLESCENTS AUTHORS: OLIVER J. MUENSTERER CITATION: THE JOURNAL OF UROLOGY (2008); 180:2155-2158. DOI:10.1016/J.JURO.2008.07.068. THE AUTHORS DESCRIBED THE INCIDENCE OF GENITOFEMORAL NERVE INJURY (GNI) ACCORDING TO THE INSTRUMENT USED, AND THE PATTERN OF SPONTANEOUS SYMPTOM RESOLUTION IN THE AFFECTED PATIENTS. THIS RETROSPECTIVE STUDY INVOLVES 27 MALE PATIENTS WHO UNDERWENT LAPAROSCOPIC VARICOCELE LIGATION BETWEEN 2004 AND 2007. THE PATIENTS WERE DIVIDED INTO 2 GROUPS; IN ULTRASONIC SHEARS GROUP, 12 MALE PATIENTS (MEAN AGE: 14.7±2.3 YEARS) USED ULTRASONIC SHEARS (ETHICON) FOR DISSECTION AND LIGATION OF THE VESSELS, AND IN ENDOSCOPIC CLIPS/COLD DISSECTION GROUP, 15 PATIENTS (MEAN AGE: 14.1± 1.8 YEARS) UNDERWENT COLD DISSECTION AND ENDOSCOPIC CLIP PLACEMENT. REPORTED COMPLICATIONS IN THE ULTRASONIC SHEARS GROUP INCLUDED GNI NERVE INJURY (N-2), AND PARESTHESIAS (N-2) WHICH RESOLVED COMPLETELY BY 8 MONTHS. IN CONCLUSION, GENITOFEMORAL NERVE INJURY MAY BE MORE FREQUENT WHEN THE DISSECTION IS PERFORMED USING ¿HOT¿ METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303015 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other