BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 12558538 · Received September 30, 2021

    Report

    Report Number
    3005075853-2021-05838
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    January 1, 2021
    Report Date
    November 3, 2021
    Product Code
    GDW
    UDI-DI
    10705036001706
    PMA / PMN Number
    K081146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/3/2021. ADDITIONAL INFORMATION PROVIDED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN ------------THE AUTHOR DOES NOT BELIEVE THAT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY EVENT YEAR KNOWN: 2021. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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: EFFICACY AND PROGNOSIS OF TOTAL LAPAROSCOPIC MODIFIED TRIANGULAR ANASTOMOSIS IN THE TREATMENT OF SIGMOID COLON CANCER. AUTHORS: XIE XIANKUN, XU YIJIAN, TANG XIANZHONG, YAO YANFANG CITATION: ANHUI MEDICAL AND PHARMACEUTICAL JOURNAL (2021); 25 (5): 910-913. DOI: 10.3969/J.ISSN.1009-6469.2021.05.015. THE AIM OF THIS STUDY IS TO INVESTIGATE THE EFFICACY AND PROGNOSIS OF TOTAL LAPAROSCOPIC MODIFIED TRIANGULAR ANASTOMOSIS IN THE TREATMENT OF SIGMOID COLON CANCER, AND TO PROVIDE REFERENCE FOR THE SELECTION OF CLINICAL TREATMENT. A TOTAL OF 98 PATIENTS WITH COLON CANCER WHO RECEIVED LAPAROSCOPIC RADICAL RESECTION OF SIGMOID COLON CANCER IN DONGGUAN PEOPLE'S HOSPITAL FROM SEPTEMBER 2018 TO JULY 2019 WERE SELECTED. THE PATIENTS WERE RANDOMLY DIVIDED INTO OBSERVATION GROUP (N = 48; 28 MALE AND 20 FEMALE; MEAN AGE OF 51.29 ± 5.49 YEARS) AND CONTROL GROUP (N = 50; 26 MALE AND 24 FEMALE; MEAN AGE OF 50.43 ± 5.61 YEARS). THE CONTROL GROUP WAS TREATED WITH LAPAROSCOPIC-ASSISTED SMALL INCISION RECONSTRUCTION, AND THE OBSERVATION GROUP WAS TREATED WITH TOTAL LAPAROSCOPIC MODIFIED TRIANGULAR ANASTOMOSIS TECHNIQUE. SURGERY WAS PERFORMED USING EC60A AND ECR0B MANUFACTURED BY JOHNSON & JOHNSON USA. THE PATIENTS WERE FOLLOWED UP FOR 6 MONTHS, AND THE SURGICAL INDICATORS, SURGICAL EFFECT, POSTOPERATIVE DIGITAL PAIN INTENSITY SCALE (NRS) SCORE, COMPLICATIONS, RECURRENCE AND METASTASIS WERE COMPARED BETWEEN THE TWO GROUPS. REPORTED COMPLICATIONS INCLUDE ANASTOMOTIC STOMA BLEEDING (N=?), ANASTOMOTIC LEAKAGE (N=?), AND ILEUS (N=?). IN CONCLUSION, THE TOTAL LAPAROSCOPIC MODIFIED TRIANGULAR ANASTOMOSIS IS EFFECTIVE IN THE TREATMENT OF SIGMOID COLON CANCER, AND CAN SHORTEN THE OPERATION TIME, PROMOTE INTESTINAL REHABILITATION AND REDUCE POSTOPERATIVE PAIN. IT HAS THE VALUE OF CLINICAL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454614 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW EC60A 10705036001706

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention