BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 21MM CURVED

    MDR report key: 14435726 · Received May 19, 2022

    Report

    Report Number
    3005075853-2022-03257
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    April 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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?

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 06/20/2022. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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: ADVANTAGEOUS SHORT-TERM OUTCOMES OF ESOPHAGOJEJUNOSTOMY USING A LINEAR STAPLER FOLLOWING OPEN TOTAL GASTRECTOMY COMPARED WITH A CIRCULAR STAPLER. AUTHORS: YUSUKE MUNEOKA, MANABU OHASHI, RIE MAKUUCHI, SATOSHI IDA, KOSHI KUMAGAI, TAKESHI SANO, SOUYA NUNOBE. CITATION: WORLD J SURG (2021) 45:2501¿2509, HTTPS://DOI.ORG/10.1007/S00268-021-06100-9. THIS STUDY RETROSPECTIVELY ANALYZED THE SURGICAL OUTCOMES AND POSTOPERATIVE NUTRITIONAL STATUS OF PATIENTS WHO UNDERWENT OPEN TOTAL GASTRECTOMY USING A LINEAR STAPLER OR A CIRCULAR STAPLER IN ESOPHAGOJEJUNOSTOMY. BETWEEN JANUARY 2014 AND DECEMBER 2019, 298 PATIENTS WHO UNDERWENT OPEN TOTAL GASTRECTOMY FOR GASTRIC CANCER WERE INCLUDED IN THE STUDY. PATIENTS WERE CATEGORIZED INTO CIRCULAR AND LINEAR GROUPS (GROUP C AND GROUP L) ACCORDING TO THE STAPLER TYPE USED FOR THE ESOPHAGOJEJUNOSTOMY. IN GROUP C, THERE WERE 227 PATIENTS WITH 166 MALES AND 61 FEMALES (MEAN AGE 65 YEARS, RANGE 21-89). IN GROUP L, THERE WERE 71 PATIENTS WITH 43 MALES AND 28 FEMALES (MEAN AGE 62 YEARS, RANGE 25-87). PATIENTS IN GROUP C UNDERWENT ESOPHAGOJEJUNOSTOMY BY THE SINGLE STAPLING TECHNIQUE OR THE DOUBLE STAPLING TECHNIQUE. IN THE SINGLE STAPLING TECHNIQUE, THE ESOPHAGUS WAS TRANSECTED AFTER MAKING A PURSE STRING SUTURE AND AN ANVIL HEAD OF COMPETITOR¿S CURVES STAPLER OR THE PROXIMATE CURVED INTRALUMINAL STAPLER (CDH; ETHICON) WAS PLACED INTO THE STUMP OF THE TRANSECTED ESOPHAGUS TRANSABDOMINALLY. IN THE DOUBLE STAPLING TECHNIQUE, AN UNKNOWN LINEAR STAPLER AND A COMPETITOR¿S CURVED STAPLER WERE USED. PATIENTS IN GROUP L UNDERWENT ESOPHAGOJEJUNOSTOMY BY THE OVERLAP METHOD USING AN UNKNOWN LINEAR STAPLER. COMPLICATIONS INCLUDE ANASTOMOTIC LEAKAGE (N=?), ANASTOMOTIC STRICTURE (N=?), ANASTOMOTIC BLEEDING (N=?) AND REFLUX ESOPHAGITIS (N=?). IN CONCLUSION, ESOPHAGOJEJUNOSTOMY USING A LINEAR STAPLER FOLLOWING OPEN TOTAL GASTRECTOMY IS EQUALLY SAFE AND POSSIBLY ADVANTAGEOUS IN ANASTOMOTIC STRICTURE, BLEEDING AND NUTRITIONAL STATUS COMPARED WITH THE USE OF A CIRCULAR STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893013 ILS 21MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH21A 10705036003441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention