BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7786236 · Received August 15, 2018

    Report

    Report Number
    2210968-2018-75193
    Event Type
    Injury
    Date Received
    August 15, 2018
    Report Date
    July 26, 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: OBES SURG. 2012; 22: 1315¿1419 (O183). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS FOR MORBID OBESITY- THE LESSER SAC APPROACH". AUTHOR: GEMMILL E.H., AHMED J. CITATION: OBES SURG. 2012; 22: 1315¿1419. MOST GASTRIC BYPASS SURGERY RECONSTRUCTIONS UTILIZE AN ANTERIOR COLIC APPROACH. EVIDENCE IS CONFLICTING ON WHETHER THIS IS SUPERIOR TO A RETROCOLIC APPROACH THROUGH THE SUPRACOLIC COMPARTMENT. THE AUTHORS PRESENTED THE RESULTS FROM A LESSER SAC/RETROCOLIC APPROACH. THE ROUX-EN-Y GASTRIC BYPASS USING A RETROCOLIC APPROACH WAS ATTEMPTED IN 226 CASES FROM DECEMBER 2009 TO FEBRUARY 2012 AT THE ROYAL DERBY HOSPITAL IN ENGLAND. DURING THE SURGICAL PROCEDURE, FOLLOWING JEJUNOJEJUNAL ANASTOMOSIS, AN ETHIBOND 0 SUTURE (ETHICON) WAS USED TO CLOSE THE MESENTERIC DEFECT, THE JEJUNUM MOSTLY RETURNED TO THE INFRA-COLIC COMPARTMENT AND ETHIBOND 0 SUTURE WAS USED TO REPAIR THE TRANSVERSE MESOCOLON DEFECT AND PETERSEN¿S SPACE. REPORTED COMPLICATION INCLUDED INTERNAL HERNIA (N-1) WHICH REQUIRED RE-OPERATION. IT WAS CONCLUDED THAT THE LESSER SAC APPROACH IS BOTH SAFE AND FEASIBLE. IT ALSO APPEARS BENEFICIAL IN PATIENTS WHO HAVE HAD PREVIOUS SURGERY OR HAVE ABDOMINAL WALL HERNIA WITH OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627125 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention