BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS 29MM, CURVED

    MDR report key: 7642195 · Received June 27, 2018

    Report

    Report Number
    3005075853-2018-10955
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    June 4, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036003509
    PMA / PMN Number
    K940967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH REVIEW OF JOURNAL ARTICLE TITLED: TOTALLY LAPAROSCOPIC SIGMOID COLECTOMY: A SIMPLE AND SAFE TECHNIQUE FOR INTRACORPOREAL ANASTOMOSIS AUTHORS: HIROKI AKAMATSU, TAKESHI OMORI, TSUKASA OYAMA, MASAYUKI TORI, SHIGEYUKI UESHIMA, MASAAKI NAKAHARA, TAKASHI ABE AND TOSHIROU NISHIDA CITATION: SURG ENDOSC (2009) 23:2605¿2609; DOI 10.1007/S00464-009-0406-6; PUBLISHED ONLINE: 6 MARCH 2009 THIS REPORT DESCRIBED AN APPLICATION OF A SIMPLE AND SAFE TECHNIQUE FOR CIRCULARLY STAPLED ESOPHAGOJEJUNOSTOMY IN LAPAROSCOPICALLY ASSISTED TOTAL GASTRECTOMY THAT ELIMINATES THE NEED FOR PLACEMENT OF A PURSE-STRING SUTURE TO TOTALLY INTRACORPOREAL ANASTOMOSIS IN SIGMOID COLECTOMY COMBINED WITH TRANSANAL EXTRACTION OF THE SPECIMEN. BETWEEN NOVEMBER 2007 AND OCTOBER 2008, 16 PATIENTS WHO UNDERWENT THIS PROCEDURE WERE INCLUDED IN THE STUDY. DURING THE SURGERY BEFORE RECONSTRUCTION, THE ANVIL HEAD OF THE CIRCULAR STAPLING DEVICE (ECS 29; ETHICON ENDO-SURGERY, (B)(4)) IS PREPARED TO BE JOINED WITH THE TROCAR ATTACHED TO THE CENTER ROD AND SECURED WITH A 2-0 MONOFILAMENT SUTURE USING A NEEDLE (PROLENE; ETHICON, INC., (B)(4)), WHICH IS BOUND AT THE HOLE OF THE TIP. THE ANVIL WITH PROLENE SUTURE IS INSERTED INTO THE COLON THROUGH THE COLOSTOMY. THE SUTURE IS PULLED OUT OF THE COLON WITH ALL THE KNOTS EXTRACTED. BETWEEN THE PENETRATED SUTURE AND OPEN WINDOW OF THE COLONIC WALL, THE COLON IS SUCCESSIVELY CLAMPED WITH A LINEAR STAPLING DEVICE USING A DISPOSABLE GASTROINTESTINAL (GI) CARTRIDGE (ECHELON 60; ETHICON ENDO-SURGERY). ALTHOUGH NO MAJOR COMPLICATIONS WERE REPORTED, ONE PATIENT DEVELOPED WOUND INFECTION. IN CONCLUSION, THIS ENABLES SURGEONS TO ACHIEVE MINIMAL INVASIVENESS SIMILAR TO THAT OF HYBRID NOTES WITHOUT NEEDING TO DEVELOP ANY SPECIAL SKILLS OR INSTRUMENTS. THIS PROCEDURE CAN BE WIDELY ACCEPTED TO BECOME A STANDARD PROCEDURE FOR RELATIVELY SMALL LESIONS IN SIGMOID AND RECTOSIGMOID SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484274 ENDO ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036003509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention