BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9448419 · Received December 10, 2019

    Report

    Report Number
    3005075853-2019-24155
    Event Type
    Injury
    Date Received
    December 10, 2019
    Report Date
    November 12, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/10/2019. DATE OF EVENT: PUBLICATION YEAR OF 2014. 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: TRANSANAL MINIMAL INVASIVE SURGERY WITH THE ENDOREC TROCAR: A LOW COST BUT EFFECTIVE TECHNIQUE. AUTHOR(S): VALÉRIE BRIDOUX & LILIAN SCHWARZ & LESLIE SUAUD & MARIE DAZZA & FRANCIS MICHOT & JEAN-JACQUES TUECH CITATION: INT J COLORECTAL DIS (2014) 29:177¿181 / DOI 10.1007/S00384-013-1789-3. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE FEASIBILITY OF TRANSANAL MINIMAL INVASIVE SURGERY (TAMIS) WITH THE ENDOREC TROCAR. BETWEEN JULY 2010 AND DEC 2012, A TOTAL OF 16 PATIENTS [N=8 MALE, AVERAGE AGE 65 YEARS (RANGE 40-87 YEARS), AVERAGE BMI 25 KG/M2 (RANGE 20-36 KG/M2)] WITH A RECTAL LESION ELIGIBLE FOR TAMIS WERE RECRUITED FOR THIS STUDY. RESECTIONS WERE PERFORMED USING A 5 MM 30° CAMERA. OTHER INSTRUMENTS WHICH WERE USED WERE AN ATRAUMATIC GRASPER AND FOR DISSECTIONS, THE HARMONIC SHEARS (HARMONIC ACE; ETHICON ENDO-SURGERY). THE DISSECTION WAS PERFORMED INTO THE PERIRECTAL PLANE TO PERFORM A FULL-THICKNESS BOWEL WALL EXCISION. COMPLICATIONS INCLUDED POSTOPERATIVE FEVER (N=1); AND SMALL FOCUS OF LOW-GRADE DYSPLASIA / SMALL RECURRENCE (N=1) WHEREIN SMALL RECURRENCE FOUND 6 MONTHS LATER AND WAS EXCISED. HARMONIC SHEARS FOR THE DISSECTIONS HAVE GOOD RESULTS IN TRANSANAL ENDOSCOPIC MICROSURGERY (TEM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242951 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other