BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 21MM CURVED

    MDR report key: 14435070 · Received May 19, 2022

    Report

    Report Number
    3005075853-2022-03254
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    October 1, 2021
    Report Date
    May 18, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003441
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNKNOWN. 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 06/20/2022. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: TRANSANAL TOTAL MESORECTAL EXCISION AND TRANSABDOMINAL ROBOTIC SURGERY FOR RECTAL CANCER: A RETROSPECTIVE STUDY. AUTHORS: HIROSHI OSHIO, YUKIKO OSHIMA , GEN YUNOME , SHINJI OKAZAKI , ICHIRO KAWAMURA , YUYA ASHITOMI , HIROAKI MUSHA , MASAAKI KAWAI , FUYUHIKO MOTOI CITATION CITE: ANNALS OF MEDICINE AND SURGERY 70 (2021) 102902. HTTPS://DOI.ORG/10.1016/J.AMSU.2021.102902. THIS STUDY AIMED TO CLARIFY THE ADVANTAGES AND DISADVANTAGES OF TRANSABDOMINAL ROBOTIC SURGERY AND LAPAROSCOPIC TATME AS A HYBRID SURGERY FOR RECTAL CANCER. THE SURGEONS ETROSPECTIVELY EVALUATED SIX PATIENTS WHO UNDERWENT HYBRID SURGERY FOR RECTAL CANCER FROM AUGUST 2018 TO APRIL 2020. BOTH CLINICAL AND PATHOLOGICAL OUTCOMES WERE ASSESSED. USED 2-0 PROLENE SUTURE TO CREATE A DOUBLE PURSE-STRING TO CLOSE THE RECTUM DISTAL TO THE LESION. USUALLY USED A PROXIMATE INTRALUMINAL STAPLER (ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) (B)(6) MALE PATIENT EXPERIENCED ANASTOMOTIC LEAKAGE. (B)(6) FEMALE PATIENT EXPERIENCED URINARY RETENTION. IN CONCLUSION HYBRID SURGERY WAS PERFORMED SAFELY AND MAY IMPROVE ONCOLOGICAL OUTCOMES FOR RECTAL CANCER. THIS TECHNIQUE HAS MANY POTENTIAL BENEFITS AND WOULD BE ALTERNATIVE OPTION IN MULTIMODAL STRATEGIES FOR RECTAL CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293741 ILS 21MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH21A 10705036003441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention