BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7759931 · Received August 7, 2018

    Report

    Report Number
    2210968-2018-74989
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    July 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: SURG ENDOSC. 2010; 24: 1200 1203. DOI: 10.1007/S00464-009-0729-3 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: THE ENDOSCOPIC U-STITCH TECHNIQUE FOR PRIMARY BUTTON PLACEMENT: AN INSTITUTION¿S EXPERIENCE" AUTHORS: NEIL NIXDORFF ¿ JENNIFER DILUCIANO ¿ TODD PONSKY ¿ WALTER CHWALS ¿ ROBERT PARRY ¿ SCOTT BOULANGER CITATION: SURG ENDOSC. 2010; 24: 1200 1203. DOI: 10.1007/S00464-009-0729-3 THE ENDOSCOPIC U-STITCH TECHNIQUE ALLOWS FOR PRIMARY BUTTON PLACEMENT WITHOUT THE NEED FOR LAPAROSCOPY. THE PURPOSE OF THIS STUDY WAS TO QUANTIFY THE COMPLETION RATE AND THE OCCURRENCE OF COMPLICATIONS WITH THIS PROCEDURE. ENDOSCOPIC U-STITCH GASTROSTOMIES WERE ATTEMPTED IN 121 PATIENTS (MEAN AGE: 40 DAYS TO 70 YEARS), WITH PRIMARY BUTTON PLACEMENT IN 115 PATIENTS AND CONVERSION TO AN OPEN PROCEDURE IN 6 PATIENTS. DURING THE SURGICAL PROCEDURE, U-STITCHES, TYPICALLY ETHIBOND 0 SUTURES (ETHICON) ON A LARGE NEEDLE, ARE INSERTED THROUGH THE SKIN. THE NEEDLE IS THEN INTRODUCED THROUGH THE ABDOMINAL WALL INTO THE GASTRIC LUMEN UNDER ENDOSCOPIC VISION AND BACK OUT AGAIN TO FORM THE U-STITCH. REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE BLOODY EMESIS (N-2), POST-OPERATIVE CELLULITIS (N-2), COLONIC PERFORATION (N-1) WHICH REQUIRED OPERATIVE REPAIR, GRANULATION TISSUE (N-2) WHICH REQUIRED OPERATIVE EXCISION, AND PERSISTENT GASTROCUTANEOUS FISTULA (N-1) WHICH REQUIRED AN OPERATIVE FISTULA CLOSURE. IN CONCLUSION, THE DATA FROM THE EXPERIENCE SHOWED THAT THE ENDOSCOPIC U-STITCH GASTROSTOMY IS A SAFE METHOD FOR PRIMARY BUTTON PLACEMENT IN INFANTS AND CHILDREN. IT AVOIDS MANY OF THE COMPLICATIONS TRADITIONALLY ASSOCIATED WITH PEG PLACEMENT AND COMPARES FAVORABLY WITH RECENTLY DESCRIBED LAPAROSCOPIC GASTROSTOMY TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601424 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention