BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 9348816 · Received November 20, 2019

    Report

    Report Number
    2210968-2019-90136
    Event Type
    Injury
    Date Received
    November 20, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (TABOTAMP) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (TABOTAMP) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: UPDATES SURG. 2013; 65:295¿299. DOI: 10.1007/S13304-013-0223-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: THE IMPACT OF THE HARMONIC FOCUSTM ON COMPLICATIONS IN THYROID SURGERY: A PROSPECTIVE MULTICENTER STUDY. AUTHOR(S): GABRIELE MATERAZZI, GIUSEPPE CARAVAGLIOS, VALERIA MATTEUCCI, ALEKSANDR AGHABABYAN, MARIO MICCOLI, PAOLO MICCOLI. CITATION: UPDATES SURG. 2013; 65:295¿299. DOI: 10.1007/S13304-013-0223-2. IN RECENT YEARS, NEWER TOOLS HAVE BEEN DEVELOPED AND USED IN THYROID SURGERY. THIS STUDY COMPARED PATIENTS WITH MULTINODULAR GOITER UNDERGOING THYROIDECTOMY USING THE HARMONIC FOCUS SHEAR (ETHICON) WITH PATIENTS UNDERGOING THE CLAMP-AND-TIE TECHNIQUE. MEDICAL RECORDS OF 268 PATIENTS WITH MULTINODULAR GOITER UNDERGOING THYROIDECTOMY FROM DECEMBER 2006 TO JULY 2011 IN TWO CENTERS IN ITALY, THE DEPARTMENT OF SURGERY OF PISA AND THE GENERAL SURGERY UNIT OF GROSSETO, WERE PROSPECTIVELY EVALUATED. PATIENTS WERE DIVIDED INTO PATIENTS WHO UNDERWENT THE HARMONIC FOCUS SHEAR (GROUP A; 141 PATIENTS; 112 FEMALE AND 29 MALE PATIENTS; AGE: 51.68 ± 12.2 YEARS) AND THE CLAMP-AND-TIE TECHNIQUE (GROUP B; 127 PATIENTS; 92 MALE AND 35 FEMALE PATIENTS; AGE: 53.97 ± 12.5 YEARS). DURING THE SURGICAL PROCEDURE, PATIENTS WHO WERE RANDOMIZED UNDER GROUP A UNDERWENT THYROIDECTOMY WITH HARMONIC FOCUS SHEAR (ETHICON). IN BOTH GROUPS, INTRAOPERATIVE NEED FOR VASCULAR CLIPS AND HEMOSTATIC AGENTS SUCH AS TABOTAMP (ETHICON) WERE ASSESSED AND ANALYZED AS WELL. IN GROUP A, REPORTED COMPLICATIONS INCLUDED TRANSIENT LARYNGEAL NERVE INJURY (0.6%), TRANSIENT HYPOCALCEMIA (2.4%), DEFINITIVE HYPOCALCEMIA (0.7%), AND POST-OPERATIVE BLEEDING (1.4%) WHICH REQUIRED RE-OPERATION. IN GROUP B, REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE BLEEDING (0.7%) WHICH REQUIRED RE-OPERATION. IT WAS REPORTED THAT THE RATES OF INJURY AND HYPOCALCEMIA WERE DUE TO TRAUMA AND ISCHEMIC EFFECT INDUCED BY THE HARMONIC TECHNIQUE. IT WAS CONCLUDED THAT THE HARMONIC FOCUS DEVICE (ETHICON) WAS SIGNIFICANTLY ASSOCIATED WITH LOWER RATE OF POSTOPERATIVE TRANSIENT HYPOCALCEMIA, DECREASED OPERATIVE TIME, SHORTER HOSPITALIZATION, AND LESSER NEED FOR HEMOSTATIC AGENTS AND POSTOPERATIVE DRAIN BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141344 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention