BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9673093 · Received February 5, 2020

    Report

    Report Number
    3005075853-2020-00771
    Event Type
    Injury
    Date Received
    February 5, 2020
    Report Date
    January 8, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2016. 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: RECTAL SHAVING FOR DEEP ENDOMETRIOSIS INFILTRATING THE RECTUM: A 5-YEAR CONTINUOUS RETROSPECTIVE SERIES. AUTHORS: HORACE ROMAN, M.D., PH.D; SALWA MOATASSIM-DRISSA, M.D.; NOEMIE MARTY, M.D.; MATHILDE MILLES, M.D.; AURELIE VALLEE, M.D.; EULALIE DESNYDER, M.D.; EMANUELA STOCHINO LOI, M.D.; CAROLE ABO, M.D. CITATION: FERTIL STERIL. 2016; 106: 1438¿45. DOI: HTTP://DX.DOI.ORG/10.1016/J.FERTNSTERT.2016.07.1097. RECTAL SHAVING IS AMONG THE FIRST TECHNIQUES USED TO TREAT DEEP ENDOMETRIOSIS INFILTRATING THE RECTUM. THE OBJECTIVES OF THIS RETROSPECTIVE STUDY WAS TO REPORT POSTOPERATIVE OUTCOME AFTER RECTAL SHAVING FOR DEEP ENDOMETRIOSIS INFILTRATING THE RECTUM. A TOTAL OF 122 CONSECUTIVE PATIENTS (AGE: 36 ± 6.9) WERE INCLUDED IN THE STUDY. IT WAS REPORTED THAT THE RECTAL SHAVING WAS PERFORMED USING THE HARMONIC SCALPEL DEVICE (ETHICON). THE DEEP SUBPERITONEAL SPACE LOCATED BETWEEN THE UTEROSACRAL LIGAMENTS AND THE RECTUM IS LONGITUDINALLY OPENED TO AVOID INJURY OF THE HYPOGASTRIC AND SPLANCHNIC NERVES. DISSECTION IS PERFORMED IN CLOSE CONTACT WITH THE LATERAL FACE OF THE RECTUM AND IS DIRECTED TOWARD THE HEALTHY RECTOVAGINAL SPACE LOCATED BELOW THE ENDOMETRIOSIS NODULE. REPORTED COMPLICATIONS INCLUDED RECTOVAGINAL FISTULA (N-1) WHICH WAS MANAGED BY COLOSTOMA AND RECTAL FISTULA (N-1) WHICH WAS MANAGED BY COLOSTOMA FOR 3 MONTHS. THE RESULTS SUGGESTS THAT RECTAL SHAVING IS A VALUABLE SURGICAL PROCEDURE, LEADING TO A LOW COMPLICATION RATE, GOOD IMPROVEMENT IN DIGESTIVE FUNCTION, AND SATISFACTORY FERTILITY OUTCOMES. THE RESULTS SUPPORT THE HYPOTHESIS THAT RECTAL SHAVING IS A VALUABLE PROCEDURE ALLOWING MANAGEMENT OF DEEP ENDOMETRIOSIS OF THE RECTUM AND OFFERING LOW POSTOPERATIVE RISK. ALTHOUGH MOST OF THE PATIENTS PRESENTED WITH RECTAL NODULES OF 1 TO 3 CM IN DIAMETER, RECTAL SHAVING IS NOT LIMITED TO SMALL NODULES AND CAN BE USED SUCCESSFULLY IN LARGE NODULES RESPONSIBLE FOR STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132781 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention