BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS 21MM, CURVED

    MDR report key: 6998731 · Received November 3, 2017

    Report

    Report Number
    3005075853-2017-05870
    Event Type
    Injury
    Date Received
    November 3, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE ARE RELATED TO AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE?

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. TYPE OF REPORTABLE EVENT: NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE ARE RELATED TO AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: LOW ANASTOMOTIC STRICTURE RATE AFTER ROUX-EN-Y GASTRIC BYPASS USING A 21-MM CIRCULAR STAPLING DEVICE. AUTHORS: A. RONDAN & S. NIJHAWAN & S. MAJID & TRACY MARTINEZ & ALAN C. WITTGROVE CITATION: OBES SURG 2012;22:1491¿1495. DOI 10.1007/S11695-012-0671-7. THE AIM OF THIS STUDY IS TO EVALUATE THE INCIDENCE OF GASTROJEJUNAL (GJ) STRICTURES USING THE 21MM CIRCULAR STAPLING DEVICE AND ITS RESPONSE TO TREATMENT WITH ENDOSCOPIC BALLOON DILATION. A RETROSPECTIVE CHART REVIEW WAS CONDUCTED OF PATIENTS WHO UNDERWENT LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) BETWEEN JANUARY 2007 AND SEPTEMBER 2010. THE GJ ANASTOMOSIS IS CREATED IN AN END-TO-END FASHION USING A ¿STEALTH¿ 21MM STAPLING DEVICE (ENDOPATH ILS ENDOSCOPIC CURVE INTRALUMINAL STAPLER). THE COHORT CONSISTED OF 338 PATIENTS (112 MEN AND 226 WOMEN WITH BMI >40 OR >35 WITH COMORBIDITIES. SIXTEEN PATIENTS DEVELOPED GJ ANASTOMOTIC STRICTURES. THESE PATIENTS CONSISTED OF 11 WOMEN (53/F, 26/F, 36/F, 19/F, 48/F, 65/F, 50/F, 45/F, 32/F, 48/F, 39/F) AND 5 MEN (55/M, 46/M, 55/M, 44/M, 53/M). SYMPTOMS RESOLVED AFTER 1 DILATION (N=12), 2 DILATIONS (N=3), OR 3 DILATIONS (N=1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780474 ENDO ILS 21MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention