BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 17819170 · Received September 26, 2023

    Report

    Report Number
    3005075853-2023-06873
    Event Type
    Death
    Date Received
    September 26, 2023
    Date of Event
    December 2, 2022
    Report Date
    June 23, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/26/2023. D4 BATCH # UNK. 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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 FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/23/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A 25 MM CIRCULAR STAPLER ANASTOMOSIS IS ASSOCIATED WITH HIGHER ANASTOMOTIC LEAKAGE RATES FOLLOWING MINIMALLY INVASIVE IVOR LEWIS OPERATION AUTHOR(S): TOBIAS HOFMANN, BIEBL MATTHIAS, SEBASTIAN KNITTER, ULI FEHRENBACH, SASCHA CHOPRA, CANDAN CETINKAYA-HOSGOR, JONAS RAAKOW, PHILIPPA SEIKA, RUPERT LANGER, JOHANN PRATSCHKE, DENECKE CHRISTIAN, AND DINO KROLL. CITATION: CLIN. MED. 2022, 11, 7177. HTTPS:/ /DOI.ORG/10.3390/JCM11237177. THIS STUDY AIMED TO EVALUATE WHETHER THE CIRCULAR STAPLER SIZE IN OESOPHAGOGASTROSTOMY AFFECTS THE POSTOPERATIVE ANASTOMOTIC LEAKAGE RATES AND RELATED MORBIDITY IN MINIMALLY INVASIVE OESOPHAGECTOMY. BETWEEN AUGUST 2014 AND JULY 2019, 119 PATIENTS WITH CANCER OF THE INTRATHORACIC ESOPHAGUS OR GASTROESOPHAGEAL JUNCTION WHO UNDERWENT THORACIC MINIMALLY INVASIVE IVOR LEWIS ESOPHAGEAL RESECTION USING A CIRCULAR STAPLER ESOPHAGOGASTRIC ANASTOMOSIS AT THE VENA AZYGOS LEVEL WERE INCLUDED IN THE STUDY. THE PATIENTS WERE GROUPED ACCORDING TO CIRCULAR STAPLER SIZE (MM): SMALL-SIZED (SS25) AND LARGE-SIZED (LS29). THERE WERE 65 PATIENTS (50 MALES, 15 FEMALES, MEDIAN AGE 63.5 YEARS) IN THE SMALL-SIZED GROUP AND 54 PATIENTS (49 MALES, 5 FEMALES, MEDIAN AGE 65.8 YEARS) IN THE LARGED-SIZED GROUP. THE PATIENTS UNDERWENT A STANDARD IVOR LEWIS OESOPHAGECTOMY WITH A 2-FIELD LYMPHADENECTOMY AND A MINIMALLY INVASIVE INTRATHORACIC CIRCULAR STAPLED ANASTOMOSIS VIA A TRANSABDOMINAL (LAPAROSCOPIC OR OPEN) AND RIGHT THORACOSCOPIC APPROACH. A 25 MM OR 29 MM DIAMETER 2-ROW CIRCULAR STAPLER (ILS; 3.5 MM, ETHICON ENDO-SURGERY) WAS USED FOR ANASTOMOSES. THERE WERE 2 ANASTOMOTIC TECHNIQUES THAT WERE APPLIED. FOR THE OR VIL DOUBLE-STAPLING ANASTOMOSIS (ONLY FOR 25 MM STAPLING), AFTER CIRCUMFERENTIAL LIBERATION OF THE OESOPHAGEAL STUMP, THE STAPLE LINE WAS ALIGNED USING TWO ENDOSCOPIC CLAMPS, AND THE 25 MM ANVIL WAS PLACED BY TRANSORAL INSERTION USING A 90 CM PVC TUB. IN THE CASE OF PURSE-STRING ANASTOMOSIS, THE STAPLE LINE WAS CUT FROM THE OESOPHAGUS, AND A 2-0 PROLENE RUNNING SUTURE (ETHICON) WAS PLACED AROUND THE OESOPHAGEAL CUT-SURFACE. AFTER INSERTION OF THE ANVIL, THE SUTURE WAS FIRMLY CLOSED, AND A SECOND 2-0 PROLENE (ETHICON) PURSE-STRING SUTURE WAS USED TO SECURE THE INSERTION SITE. THE ANVIL-CORRESPONDING 25- OR 29-MM CIRCULAR STAPLER WAS INSERTED BY TERMINAL INCISION OF THE GASTRIC TUBE THROUGH THE RETRIEVAL INCISION IN THE 4TH INTERCOSTAL SPACE. FOLLOWING COMPLETION OF THE END-TO-SIDE ANASTOMOSIS, THE STAPLER WAS REMOVED, AND THE GASTRIC INCISION WAS CLOSED USING A LINEAR ENDOSCOPIC STAPLER (MANUFACTURER: UNKNOWN). REPEAT ENDOSCOPY USING AIR-LEAK TESTING CONFIRMED THE PRIMARY INTEGRITY OF THE ANASTOMOSIS, AND A NASOGASTRIC TUBE WAS PLACED FOR 48 H. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE (N=14), ANASTOMOTIC STRICTURE (N=5), PYLORIC STENOSIS (N=28), 30-DAY MORTALITY (N=1), AND 90-DAY MORTALITY (N=5). IN CONCLUSION, THIS SINGLE-CENTRE COHORT STUDY DEMONSTRATED THAT THE INCIDENCE OF ANASTOMOTIC LEAKAGE AND RELATED MAJOR MORBIDITY AFTER MINIMALLY INVASIVE OESOPHAGECTOMY WAS SIGNIFICANTLY LOWER USING THE LARGE-SIZED (29 MM DIAMETER) CIRCULAR STAPLER THAN USING A 25 MM DIAMETER STAPLER FOR MINIMALLY INVASIVE END-TO-SIDE OESOPHAGOGASTROSTOMIES PERFORMED AT THE LEVEL OF THE AZYGOS VEIN. THEREFORE, WE ADVOCATE USING A LARGE-DIAMETER STAPLER WHENEVER POSSIBLE FOR STANDARD MINIMALLY INVASIVE IVOR LEWIS RESECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018786 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 Death| R