BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 6994935 · Received November 1, 2017

    Report

    Report Number
    3005075853-2017-05828
    Event Type
    Injury
    Date Received
    November 1, 2017
    Report Date
    October 4, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE: COMPARISON OF HAND-SEWN, LINEAR-STAPLED, AND CIRCULAR-STAPLED GASTROJEJUNOSTOMY IN LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS AUTHORS: FRANK P. BENDEWALD, JENNIFER N. CHOI, LORIE S. BLYTHE, DON J. SELZER, JOHN H. DITSLEAR, SAMER G. MATTAR. CITATION: OBES SURG 2011;21:1671-1675. DOI 10.1007/S11695-011-0470-6. IN THIS ARTICLE, THE AUTHORS PRESENT THEIR EXPERIENCE WITH 3 GASTROJEJUNOSTOMY TECHNIQUES AND ATTEMPT TO DETERMINE WHICH TECHNIQUE IS ASSOCIATED WITH THE FEWEST ANASTOMOTIC COMPLICATIONS WITHIN THE FIRST 60 POSTOPERATIVE DAYS. THE 835 PATIENTS UNDERGOING BARIATRIC SURGERY AT A SINGLE ACADEMIC INSTITUTION FROM NOVEMBER 2004 THROUGH DECEMBER 2009 WAS REVIEWED. THE TYPE OF GASTROJEJUNOSTOMY ANASTOMOSIS (GJA) PERFORMED [HAND-SEWN (HSA), LINEAR-STAPLED LSA, OR 25-MM CIRCULAR STAPLED (CSA)] WAS RECORDED AND POSTOPERATIVE GASTROJEJUNOSTOMY LEAK, STRICTURE, AND MARGINAL ULCER WERE IDENTIFIED. IN THE HSA TECHNIQUE (N=181; 157 FEMALE, 24 MALE; MEAN AGE 45.7 YEARS; MEAN BMI 48.6 KG/M2), CONTINUOUS 2-0 POLYDIOXANONE SUTURE IS USED TO COMPLETE THE 2-LAYER ANASTOMOSIS. IN THE CSA TECHNIQUE (N=140; 118 FEMALE; 22 MALE; MEAN AGE 45.8 YEARS; MEAN BMI 47.8 YEARS), AN 25-MM ILS CIRCULAR STAPLER WAS USED. COMPLICATIONS IN THE LSA AND CSA GROUP INCLUDE: LEAK (LSA, N=5), STRICTURE (LSA, N=31; CSA, N=6), MARGINAL ULCER (LSA, N=41; CSA, N=5), TROCAR SITE INFECTION RATE (LSA, 2.5%; CSA 4.3%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774501 ENDOPATH STEALTH CIR STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention