BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8143718 · Received December 7, 2018

    Report

    Report Number
    2210968-2018-77592
    Event Type
    Injury
    Date Received
    December 7, 2018
    Report Date
    November 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 ENDOSC (2011) 25:2742¿2747; DOI 10.1007/S00464-011-1574-8. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC LEFT COLECTOMY COMBINED WITH NATURAL ORIFICE ACCESS: OPERATIVE TECHNIQUE AND INITIAL RESULTS" AUTHOR(S): STEFANO SAAD, HISAHIRO HOSOGI. CITATION: SURG ENDOSC (2011) 25:2742¿2747; DOI 10.1007/S00464-011-1574-8. THIS STUDY AIMED TO DESCRIBE A NEW APPROACH THAT COMBINE CLASSICAL LAPAROSCOPIC LEFT COLON RESECTION AND NATURAL ORIFICE ACCESS USING AN OPERATING RECTOSCOPE, WITH THE AIM TO MINIMIZE ABDOMINAL WALL TRAUMA. FROM NOV2009 TO MAY2010, 15 PATIENTS (N=9 MALE AND N=6 FEMALE; MEDIAN AGE OF 61 YEARS [46-76 YEARS]) WHO UNDERWENT LAPAROSCOPIC LEFT COLON RESECTION FOR DIVERTICULAR DISEASE (N=9) OR SMALL TUMORS WITH A MAXIMUM DIAMETER OF 4 CM (N=6). IN THE PROCEDURE, A 2-0 ETHILON II WITH STRAIGHT NEEDLE WAS TIED TO THE ROD OF THE ANVIL WHICH WAS USED TO PUNCTURE THE ANTERIOR WALL OF THE PROXIMAL COLON; THE SPIKE OF THE ANVIL GOES TO THE SAME PUNCTURED HOLE. THE PAIN LEVEL ASSESSED BY VAS SCORE WAS VERY LOW IN ALL PATIENTS AND WERE MANAGED BY APPLICATION OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS. ONLY 3 PATIENTS NEEDED ADDITIONAL OPIOID ANALGESIA, LIMITED TO POSTOPERATIVE DAY 1. THE STRAIGHT-NEEDLE ANVIL TECHNIQUE ENABLES THE SURGEON TO PLACE THE ANVIL ROD AT AN OPTIMAL POSITION OF THE ANTERIOR WALL OF THE PROXIMAL COLON IN A QUICK AND EASY WAY. IN THIS STUDY, IT WAS ABLE TO DEMONSTRATE THAT AVOIDANCE OF THE MINILAPAROTOMY REDUCES POSTOPERATIVE PAIN TO THE EXTENT THAT PAIN CONTROL COULD BE MANAGED WITHOUT OPIOID ANALGESIA FOR THE MAJORITY OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981628 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention