BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9443593 · Received December 10, 2019

    Report

    Report Number
    2210968-2019-90688
    Event Type
    Injury
    Date Received
    December 10, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: LARYNGOSCOPE (2000); 110:938-941 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL AUTHOR: "TITLE : A NOVEL APPROACH TO LARYNGEAL SUSPENSION AFTER PARTIAL LARYNGECTOMY". AUTHOR : RENATO J. GIACCHI, MD; M. ABRAHAM KURIAKOSE, MD, DDS, PRCS; DAVID KAUFMAN, MD; MARK D. DELACURE, MD, FAGS. CITATION: LARYNGOSCOPE (2000); 110:938-941. THE AUTHORS PRESENTED THEIR INITIAL EXPERIENCE USING SEVEN ANCHORS TO ACCOMPLISH LARYNGEAL SUSPENSION IN TWO PATIENTS AFTER A STANDARD HORIZONTAL SUPRAGLOTTIC LARYNGECTOMY. PATIENT 1, A (B)(6) YEAR OLD MALE PATIENT WITH A DIAGNOSIS OF T2N1M0 SQUAMOUS CELL CARCINOMA OF THE EPIGLOTTIS IN WHICH A LARYNGEAL SUSPENSION WAS PERFORMED USING 2 SUTURE ANCHORS JUXTAPOSED TO 4 SIZE 0 SUTURES. PATIENT 2, A (B)(6) YEAR OLD MALE PATIENT WITH A DIAGNOSIS OF A T2N1M0 SQUAMOUS CELL CARCINOMA OF THE EPIGLOTTIS IN WHICH 5 ANCHORS ALONE WERE USED TO SUSPEND THE LARYNGEAL REMNANT TO THE HYOID BONE. FOR BOTH PATIENTS, THE SUTURE ANCHOR WITH A BULLET-SHAPED TIP AT ONE END OF THE SHAFT AND, AT THE OTHER END, AN EYELET THAT IS PRELOADED WITH A 4-0 ETHIBOND (ETHICON) BRAIDED POLYESTER SUTURE, WHICH IS DOUBLE ARMED WITH C-1 TAPER NEEDLES WAS USED. ONE ANCHOR IN PATIENT 2 DID NOT APPEAR TO BE SEATED WELL WITHIN THE CARTILAGE AND WAS REMOVED. A SIZE 0 SUTURE WAS REPLACED THROUGH THE PILOT HOLE OF THIS ANCHOR AND ALL SUTURES WERE TIED AROUND THE HYOID BONE. DECANNULATION WAS PERFORMED AND THE PATIENT WAS DISCHARGED IN 2 WEEKS TOLERATING A NORMAL DIET INCLUDING THIN LIQUIDS. IN CONCLUSION, THIS NOVEL APPROACH IS TECHNICALLY EASIER AND MORE EFFICIENT THAN TRADITIONAL METHODS AND ACCOMPLISHES DISTRIBUTION OF STRESS FORCES ON THE THYROID CARTILAGE REMNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242506 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention