BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9528372 · Received December 28, 2019

    Report

    Report Number
    3005075853-2019-24767
    Event Type
    Injury
    Date Received
    December 28, 2019
    Date of Event
    January 1, 2007
    Report Date
    December 3, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/28/2019. DATE OF EVENT: PUBLICATION YEAR OF 2007. 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: ENDOSCOPIC TRANSAXILLARY APPROACH TO THE THYROID GLAND: OUR EARLY EXPERIENCE. AUTHORS: T. D. DUNCAN, Q. RASHID, F. SPEIGHTS, AND I. EJEH. CITATION: SURG ENDOSC (2007) 21: 2166¿2171. DOI: 10.1007/S00464-007-9325-6. THE OBJECTIVE OF THIS STUDY IS TO PRESENT AN EARLY SERIES OF ENDOSCOPIC THYROIDECTOMY VIA AN AXILLARY APPROACH AND HEREIN REPORT RESULTS OF THE AUTHORS¿ EXPERIENCE WITH THIS TECHNIQUE. THERE WERE 32 PATIENTS (30 FEMALES AND 2 MALES), AGES RANGING FROM 19 TO 71 YEARS (MEAN AGE, 33 YEARS), WHO UNDERWENT ENDOSCOPIC THYROID LOBECTOMY AND ISTHMECTOMY PROCEDURES FOR UNILATERAL THYROID DISEASE FROM AUGUST 2003 TO AUGUST 2005. DISSECTION WAS CARRIED OUT USING A 5-MM HARMONIC SCALPEL (ETHICON ENDO-SURGERY¿). DISSECTION WAS DIRECTED TOWARD THE IPSILATERAL STERNOCLEIDOMASTOID MUSCLE. SMALLER VESSELS WERE DIVIDED WITH THE HARMONIC SCALPEL. TEMPORARY HOARSENESS WAS REPORTED IN 2 PATIENTS. COMPLETE RESOLUTION OF HOARSENESS WAS NOTED WITHIN 3 WEEKS OF OPERATION. POSTOPERATIVE BLEEDING IN ONE PATIENT REQUIRED READMISSION. BLEEDING WAS CONTROLLED ENDOSCOPICALLY BY APPLYING MONOPOLAR CAUTERY TO THE IDENTIFIED BLEEDING SITE. CHEST WALL PARESTHESIAS WERE EXPERIENCED BY 3 PATIENTS THAT PERSISTED LONGER THAN 8 WEEKS THAT RESOLVED WITHIN AN AVERAGE OF 16 WEEKS FOLLOWING SURGERY. EIGHT PATIENTS COMPLAINED OF SIGNIFICANT POSTOPERATIVE PAIN AND PROLONGED DISCOMFORT OVER THE DISSECTED ANTERIOR CHEST WALL DURING THE EARLY PART OF THE SERIES. THE FOLLOWING POSTOPERATIVE PAIN SCORES WERE NOTED: WORST EVER POSTOPERATIVE PAIN/DISCOMFORT (DAY 1) WAS REPORTED BY 2 PATIENTS, SEVERE POSTOPERATIVE PAIN/DISCOMFORT (DAY 1) WAS REPORTED BY 6 PATIENTS , MODERATE POSTOPERATIVE PAIN/DISCOMFORT (DAY 3) WAS REPORTED BY 5 PATIENTS, POSTOPERATIVE PAIN/DISCOMFORT (DAY 3) WAS REPORTED BY 3 PATIENTS, MODERATE POSTOPERATIVE PAIN/DISCOMFORT (DAY 7) WAS REPORTED BY 6 PATIENTS, AND POSTOPERATIVE PAIN/DISCOMFORT (DAY 7) WAS REPORTED BY 2 PATIENTS. ADDITION OF TOPICAL ANALGESIA THROUGH A TUMESCENT SOLUTION (N=24) WAS USED TO IMPROVE POSTOPERATIVE PAIN CONTROL. PAIN CONTROL IS PROLONGED BEYOND THE IMMEDIATE POSTOPERATIVE PERIOD AND INTO THE CONVALESCENT STAGE. THE FOLLOWING POSTOPERATIVE PAIN SCORES WERE NOTED: SEVERE POSTOPERATIVE PAIN/DISCOMFORT (DAY 1) WAS REPORTED BY 1 PATIENT, MODERATE POSTOPERATIVE PAIN/DISCOMFORT (DAY 1) WAS REPORTED BY 1 PATIENT, POSTOPERATIVE PAIN/DISCOMFORT (DAY 1) WAS REPORTED BY 5 PATIENTS, POSTOPERATIVE PAIN/DISCOMFORT (DAY 3) WAS REPORTED BY 13 PATIENTS, AND POSTOPERATIVE PAIN/DISCOMFORT (DAY 7) WAS REPORTED BY 10 PATIENTS. THE AUTHORS REPORTED THAT TRANSAXILLARY ENDOSCOPIC THYROIDECTOMY IS A SAFE AND FEASIBLE ALTERNATIVE TO THE TRADITIONAL OPEN SURGICAL APPROACH IN SELECT PATIENTS REQUIRING SURGICAL REMOVAL OF THE THYROID GLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323197 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1