BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN)

    MDR report key: 14841849 · Received June 28, 2022

    Report

    Report Number
    3005075853-2022-04220
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    January 1, 2021
    Report Date
    June 28, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONLY EVENT YEAR KNOWN: 2021. 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. 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 07/25/2022. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? RESPONSE: CONFIRMED WITH THE AUTHOR, ALL THE COMPLICATIONS MENTIONED IN THE ARTICLE WERE NOT RELATED TO ETHICON DEVICES . UPON REVIEW OF THE INFORMATION PROVIDED IN H10, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A PROSPECTIVE CONTROLLED STUDY OF TOTAL LAPAROSCOPIC RIGHT HEMICOLECTOMY FOR THE TREATMENT OF RIGHT COLON CANCER AUTHORS: ZHU PENGCHENG, LI MING, MIAO WENZHONG, GU FENG, JIANG JIANLONG, LU ZHIHUA CITATION: CHINESE JOURNAL OF GENERAL PRACTICE,· MARCH 2021,VOL. 19,NO. 3 DOI: (B)(4). ISSN. 1674 - 4152. 001810 THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE CLINICAL EFFECT OF TOTAL LAPAROSCOPIC RIGHT HEMICOLECTOMY FOR RIGHT COLON CANCER BY COMPARING WITH LAPAROSCOPIC-ASSISTED RIGHT HEMICOLECTOMY. A PROSPECTIVE CONTROLLED STUDY WAS CONDUCTED IN WHICH PATIENTS WITH RIGHT COLON CANCER ADMITTED TO THE DEPARTMENT OF GENERAL SURGERY OF OUR HOSPITAL FROM JANUARY 2014 TO DECEMBER 2018 WERE DIVIDED INTO EXTRACORPOREAL ANASTOMOSIS (EA) GROUP AND INTRACORPOREAL ANASTOMOSIS (IA) GROUP ACCORDING TO THE INCLUSION AND EXCLUSION CRITERIA ACCORDING TO DIFFERENT ANASTOMOSIS METHODS. LINEAR CUTTER STAPLER (ETHICON, JOHNSON & JOHNSON, USA) WAS USED DURING THE PROCEDURE. REPORTED COMPLICATIONS INCLUDED PAIN (N=13), NAUSEA AND VOMITING (N=14), WOUND INFECTION (N=13), BLEEDING (N=7), ANASTOMOTIC LEAKAGE (N=5) IN CONCLUSION COMPARED WITH LAPAROSCOPIC-ASSISTED RIGHT HEMICOLECTOMY, TOTAL LAPAROSCOPIC RIGHT HEMICOLECTOMY CAN ACCELERATE THE POSTOPERATIVE RECOVERY OF PATIENTS, WITHOUT INCREASING THE INCIDENCE RATE OF SURGERY, DELAYING THE OPERATION TIME AND REDUCING THE LONG-TERM SURVIVAL RATE. IT IS A SAFE AND RELIABLE SURGICAL METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735092 PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown