BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7776835 · Received August 13, 2018

    Report

    Report Number
    2210968-2018-75101
    Event Type
    Injury
    Date Received
    August 13, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: SURG LAPAROSC ENDOSC PERCUTAN TECH 2010;20:E84¿E88 - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : A MODIFIED APPROACH TO LAPAROSCOPIC ANTIREFLUX SURGERY MAY DECREASE POSTOPERATIVE DYSPHAGIA AND GAS BLOAT SYNDROME. AUTHOR: ABDULZAHRA HUSSAIN, FRCS, FICMS, DIPLOMA (GENERAL SURGERY), HIND MAHMOOD, MB, CHB, JACKIE NICHOLLS, RGN, AND SHAMSI EL-HASANI, MBCHB, FRCS. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2010;20:E84¿E88. THE AIM OF THIS STUDY WAS TO REDUCE THE INCIDENCE OF DYSPHAGIA AND GAS BLOAT SYNDROME AFTER LAPAROSCOPIC ANTIREFLUX SURGERY (ARS). FIFTY-SEVEN PATIENTS UNDERWENT THE SPIRAL WRAP (SW) TECHNIQUE FOR SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE (GERD) FROM FEBRUARY 2007 TO FEBRUARY 2008. THIRTY (52.63%) MEN AND 27 (47.36%) WOMEN WERE INCLUDED IN THIS STUDY. THE MEAN AGE WAS 51 YEARS (RANGE: 19 TO 75 Y). THE SURGICAL PROCEDURE STARTED BY APPLYING AN ETHIBOND STITCH IN THE LOWER END OF BOTH PILLARS OF THE RIGHT CRURA TO APPROXIMATE THEM TO NARROW THE ESOPHAGEAL HIATUS. THIS SUTURE IS LEFT IN SITU FOR THE NEXT STEP OF THE SURGICAL PROCEDURE. MORBIDITY INCLUDED 1 INTRAOPERATIVE BLEEDING WHICH WAS MANAGED CONSERVATIVELY DURING THE OPERATION. PORT INFECTION WAS REPORTED IN 1 PATIENT AND LEFT SHOULDER PAIN IN 1 PATIENT. IN CONCLUSION, THE SW PROVIDED FIXATION OF THE GOJ IN THE ABDOMINAL CAVITY WITH AN ADEQUATE LENGTH OF INTRA-ABDOMINAL ESOPHAGUS. THE ANTIREFLUX MECHANISM WAS ENSURED AND CONSTRUCTED INTO A SEQUENTIAL MANNER AROUND THE ABDOMINAL ESOPHAGUS. THIS WAS ASSOCIATED WITH ACCEPTABLE MORBIDITY AND LOW INCIDENCE OF DYSPHAGIA AND GAS BLOAT SYNDROME. SW MAY PREVENT OR DECREASE THE INCIDENCE OF WRAP MIGRATION, PERSISTENT POSTOPERATIVE DYSPHAGIA, AND GAS BLOAT SYNDROME ON LONG-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618679 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention