BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 7720784 · Received July 25, 2018

    Report

    Report Number
    3005075853-2018-11552
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    September 1, 2000
    Report Date
    June 28, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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

    TITLE: A Y-SHAPED VINYL HOOD THAT CREATES PNEUMOPERITONEUM IN LAPAROSCOPIC RECTAL CANCER SURGERY (Y-HOOD METHOD.): A NEW TECHNIQUE FOR LAPAROSCOPIC LOW ANTERIOR RESECTION. AUTHOR : SHOICHI FUJII , MITSUYOSHI OTA , SHIGERU YAMAGISHI , CHIKARA KUNISAKI , SHUNICHI OSADA , HIROKAZU SUWA , YASUSHI ICHIKAWA , HIROSHI SHIMADA CITATION: SURG ENDOSC (2010) 24:476¿484; DOI 10.1007/S00464-009-0564-6. THIS STUDY AIMED TO PRESENT AN EFFECTIVE METHOD OF ANAL LAVAGE AND EXCISION IN LAPAROSCOPIC LOW ANTERIOR RESECTION. BETWEEN SEP2000 AND OCT2008, 107 PATIENTS (N=64 MALE AND N=43 FEMALE; AGE OF 64.0±10.1 YEARS) UNDERWENT LAPAROSCOPIC LOW ANTERIOR RESECTION USING A DOUBLE STAPLING TECHNIQUE WHICH WAS COMPARED TO THE SHORT TERM RESULTS OF THE PATIENTS WHO UTILIZED Y-HOOD METHOD (N=28; N=16 MALE AND N=12 FEMALE; AGE OF 64.8±8.6 YEARS) FROM MAY2005 TO OCTOBER 2008. IN MULTIPLE STAPLING TECHNIQUE, THE ENDOGIA97 WAS USED IN 97 CASES AND THE ECHELON IN 10 CASES. IN Y-HOOD METHOD, THE CONTOUR CURVEDCUTTER WAS USED IN 27 CASES AND PROXIMATE LINEAR STAPLER TL-30 IN 1 CASE. POSTOPERATIVE FINDINGS INCLUDED ANASTOMOTIC LEAKAGE (N=12 MULTIPLE STAPLING GROUP; N=2 Y-HOOD GROUP) AND SURGICAL SITE INFECTION (N=13 MULTIPLE STAPLING GROUP; N=4 Y-HOOD GROUP). OF THE 12 CASES, MULTIPLE STAPLING FOR RECTAL TRANSECTION WAS PERFORMED TWICE IN 5 CASES, THREE TIMES IN 5 CASES, AND FOUR TIMES IN 2 CASES. MULTIVARIATE ANALYSIS INDICATED THAT RISK FACTORS FOR ANASTOMOTIC LEAKAGE WERE THE NUMBER OF TIMES STAPLING FOR RECTAL TRANSECTION WAS PERFORMED AND THE HEIGHT OF THE ANASTOMOSIS. THE Y-HOOD METHOD ENABLES OPERATIONS TO BE PERFORMED WITHIN THE INTERIOR OF THE PELVIS WITHOUT REDUCING THE NUMBER OF PORTS BECAUSE THE INSTRUMENTS CAN BE ACCESSED USING MINILAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559866 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention