BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 22206943 · Received June 13, 2025

    Report

    Report Number
    3005075853-2025-04518
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    January 1, 2023
    Report Date
    July 10, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/13/2025. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. ATTEMPT BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE A RESPONSE HAS NOT BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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: 7/10/2025. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN -NO UPON REVIEW OF THE ADDITIONAL INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A SERIOUS INJURY AND IS BEING CONSIDERED A MALFUNCTION.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LIU W, GUO Y, QIU Z, LIU X, ZHANG J, SUN Z. A MODIFIED PURSE-STRING STAPLING TECHNIQUE FOR INTRACORPOREAL CIRCULAR STAPLED ESOPHAGOJEJUNOSTOMY DURING LAPAROSCOPIC TOTAL GASTRECTOMY: COMPARISON WITH EXTRACORPOREAL RECONSTRUCTION TECHNIQUE. J LAPAROENDOSC ADV SURG TECH A. 2023 NOV;33(11):1074-1080. DOI: 10.1089/LAP.2023.0253. EPUB 2023 OCT 3. PMID: 37787916. THE AIM OF THIS STUDY IS TO PRESENT OUR MODIFIED PURSE-STRING STAPLING TECHNIQUE FOR INTRACORPOREAL EJ AND COMPARE IT WITH EXTRACORPOREAL EJ VIA MINI-LAPAROTOMY DURING LAPAROSCOPIC TOTAL GASTRECTOMY IN PATIENTS WITH GASTRIC CANCER. BETWEEN MARCH 2014 AND JUNE 2022, A TOTAL OF 293 PATIENTS, 92 PATIENTS WHO UNDERWENT INTRACORPOREAL CIRCULAR STAPLED EJ USING AN IMPROVED PURSE-STRING STAPLING TECHNIQUE WHILE USING A 25-MM CIRCULAR STAPLER (ECS; ETHICON ENDO-SURGERY) AND A 45-MM ENDOSCOPIC LINEAR STAPLER (ETS45; ETHICON ENDO-SURGERY) AND 121 PATIENTS WHO UNDERWENT EXTRACORPOREAL CIRCULAR STAPLED EJ VIA MINI-LAPAROTOMY. REPORTED COMPLICATIONS ARE N=1; LEAKAGE TREATMENT: ENHANCED DRAINAGE AND SUPPORTIVE TREATMENT N=3; STENOSIS TREATMENT: ENDOSCOPIC BALLOON DILATION N=2; BLEEDING TREATMENT: NOT REPORTED N=?; POSTOPERATIVE VAS SCORE TREATMENT: NOT REPORTED IN CONCLUSION, THE MODIFIED INTRACORPOREAL PURSE-STRING STAPLING TECHNIQUE FOR EJ DURING LAPAROSCOPIC TOTAL GASTRECTOMY IS A SAFE AND VIABLE OPTION, EXHIBITING LESS INVASIVENESS AND COMPARABLE OUTCOMES WITH THE EXTRACORPOREAL RECONSTRUCTION METHOD, ESPECIALLY SUITABLE FOR OBESE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343305 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other