BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 33MM, CURVED

    MDR report key: 10453775 · Received August 26, 2020

    Report

    Report Number
    3005075853-2020-04339
    Event Type
    Injury
    Date Received
    August 26, 2020
    Report Date
    August 6, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003472
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: SEPTEMBER 2015 TO DECEMBER 2018. 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/BATCH NUMBER HAS NOT BEEN PROVIDED. 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. WHAT SPECIFIC EVENT REQUIRED THE BLOOD TRANSFUSION? DOES THE SURGEON BELIEVE THAT THE CDH33A CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE BLEED DESCRIBED IN THE ARTICLE? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: FEASIBILITY, COMPLICATIONS, AND RECURRENCE AFTER DISCOID RESECTION FOR COLORECTAL ENDOMETRIOSIS: A SERIES OF 93 CASES AUTHOR(S): AUDE JAYOT, MD; SOFIANE BENDIFALLAH, MD, PHD; CAROLE ABO, MD; ALEXANDRA ARFI, MD; CLEMENTINE OWEN, MD; AND EMILE DARAI, MD, PHD CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2020) 27, 212-219. / HTTPS://DOI.ORG/10.1016/J.JMIG.2019.07.011. THE PURPOSE OF THIS PROSPECTIVE COHORT STUDY WAS TO EVALUATE THE RATE OF CONVERSION TO SEGMENTAL RESECTION, THE NEED FOR DOUBLE DISCOID RESECTION, AND THE COMPLICATION AND RECURRENCE RATES IN WOMEN UNDERGOING DISCOID RESECTION FOR COLORECTAL ENDOMETRIOSIS. FROM SEPTEMBER 2015 TO DECEMBER 2018, A TOTAL OF 93 WOMEN [MEDIAN AGE 34 YEARS (RANGE 19-59 YEARS), MEDIAN BMI 23 KG/M2 (RANGE 17-37 KG/M2)] UNDERWENT DISCOID RESECTION FOR COLORECTAL ENDOMETRIOSIS. DISCOID RESECTION WAS THEN PERFORMED USING A TRANSANAL CIRCULAR STAPLER (CDH33A; ENDO-SURGERY, ETHICON). INTRAOPERATIVE COMPLICATION INCLUDED HEMORRHAGE (N=1). POSTOPERATIVE COMPLICATIONS INCLUDED RECTAL BLEEDING (N=1), WOUND INFECTION (N=2), PARALYTIC ILEUS (N=1), AND RECURRENCE (N=1). THE PRESENT STUDY CONFIRMS THAT DISCOID RESECTION IS PROBABLY THE BEST OPTION FOR SMALL LESIONS BECAUSE OF ITS HIGH FEASIBILITY AND LOW COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922007 ILS 33MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH33A 10705036003472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention