BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9528375 · Received December 28, 2019

    Report

    Report Number
    3005075853-2019-24770
    Event Type
    Injury
    Date Received
    December 28, 2019
    Date of Event
    January 1, 2013
    Report Date
    December 3, 2019
    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 SENT: 12/28/2019. DATE OF EVENT: PUBLICATION YEAR OF 2013. 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: LAPAROSCOPIC RESECTION OF RETRORECTAL TUMORS: A FEASIBILITY STUDY IN 12 CONSECUTIVE PATIENTS AUTHOR : JULIE DUCLOS, LE´ON MAGGIORI, MAGALY ZAPPA, MARIANNE FERRON, YVES PANIS. CITATION: SURG ENDOSC (2014) 28:1223¿1229. DOI 10.1007/S00464-013-3312-X. THE OBJECTIVE OF THIS STUDY WAS TO ASSESS THE RESULTS OF LAPAROSCOPY FOR THE TREATMENT OF RETRORECTAL TUMORS (RRT). A TOTAL OF 12 FEMALE PATIENTS, AGES RANGING FROM 22 TO 89 YEARS (MEAN AGE, 55 YEARS), UNDERWENT LAPAROSCOPIC RESECTION FOR RRT BETWEEN 2003 AND 2012. A LAPAROSCOPIC APPROACH FOR RRT SURGICAL MANAGEMENT WAS PERFORMED. ALL DISSECTION WAS DONE USING ULTRASONIC SHEARS (HARMONIC SCALPEL, ETHICON ENDOSURGERY, NORDERSTEDT, GERMANY). INTRA-OPERATIVE PRESACRAL BLEEDING (N=1) AND TECHNICAL DIFFICULTIES OBTAINING EXPOSURE (N=1) REQUIRED CONVERSION TO LAPAROTOMY. AN INTRAOPERATIVE RECTAL INJURY OCCURRED IN 1 PATIENT DURING THE RESECTION OF A SMALL TUMOR. THE INJURY WAS REPAIRED BY SUTURING AND A TEMPORARY DIVERTING LOOP ILEOSTOMY WAS PERFORMED. THIS PATIENT UNDERWENT AN UNCOMPLICATED INTESTINAL CONTINUITY RESTORATION 2 MONTHS AFTER THE INDEX PROCEDURE. TWO PATIENTS DEVELOPED POSTOPERATIVE URINARY TRACT INFECTION THAT WAS TREATED WITH ANTIBIOTICS. IN CONCLUSION, THE AUTHORS REPORTED THAT LAPAROSCOPIC RESECTION FOR RRT SEEMS FEASIBLE, SAFE AND THAT THIS CAN BE A VALID ALTERNATIVE TO STANDARD KRASKE OR OPEN ABDOMINAL APPROACHES FOR THE TREATMENT OF RRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323204 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention