BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN)

    MDR report key: 22435903 · Received July 8, 2025

    Report

    Report Number
    3005075853-2025-05241
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    May 1, 2022
    Report Date
    July 15, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    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: 7/8/2025 D4: BATCH # UNK. 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. 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: 7/15/2025. CORRECTED DATA: B1, H1. 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? -NO. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: THE EFFECT OF MODIFIED TUBULAR GASTROESOPHAGEAL SUBSTITUTION ON POSTOPERATIVE PULMONARY FUNCTION AND GASTROESOPHAGEAL FUNCTION IN PATIENTS WITH ESOPHAGEAL CARCINOMA AUTHORS: ZHAO SHANHU 1, 2, MA XIAOHONG CITATION: TUMOR PROGRESSION, MAY 2022 VOL. 20 NO. 10. THE AIM OF THIS STUDY IS TO INVESTIGATE THE EFFECT OF IMPROVING PULMONARY FUNCTION AND GASTROESOPHAGEAL FUNCTION IN PATIENTS AFTER ESOPHAGEAL CANCER SURGERY. BETWEEN JANUARY 2018 TO APRIL 2021, 90 PATIENTS WITH ESOPHAGEAL CARCINOMA WERE DIVIDED INTO OBSERVATION GROUP (N = 45) AND CONTROL GROUP (N = 45). THE PATIENTS IN THE CONTROL GROUP WERE TREATED WITH TOTAL GASTRIC RECONSTRUCTION, AND THE PATIENTS IN THE OBSERVATION GROUP WERE TREATED WITH MODIFIED TUBULAR GASTRIC REPLACEMENT OF ESOPHAGEAL POSTERIOR GASTRIC TUBE RECONSTRUCTION. THE PATIENTS IN THE OBSERVATION GROUP WERE GIVEN IMPROVED TUBULAR STOMACH INSTEAD OF ESOPHAGUS FOR DIGESTIVE TRACT RECONSTRUCTION. TAKING THE ANGLE OF STOMACH AS THE STARTING POINT, THE PROXIMAL END OF THE RIGHT GASTRIC ARTERY WAS TRANSECTED AND LIGATED. AFTER SUTURE AND LIGATION, 3 ~ 4 JOHNSON & JOHNSON LINEAR CUTTER STAPLERS WERE USED TO PLACE PARALLEL TO THE GREATER CURVATURE OF THE STOMACH. REPORTED COMPLICATIONS ARE: 3 ~ 4 LINEAR CUTTER STAPLERS (ETHICON ENDOSURGERY) ANASTOMOTIC LEAKAGE (N=1). TREATMENT: NOT REPORTED ANASTOMOTIC STENOSIS (N=3). TREATMENT: NOT REPORTED ESOPHAGITIS (N=2). TREATMENT: NOT REPORTED IN CONCLUSION, THE IMPROVED TUBULAR STOMACH INSTEAD OF ESOPHAGUS CAN PROMOTE THE RECOVERY OF PULMONARY FUNCTION AND GASTRIC MOTILITY IN PATIENTS AFTER ESOPHAGEAL CANCER SURGERY, REDUCE GASTROESOPHAGEAL FISTULA, WITH HIGH SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072427 PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention