BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 24777927 · Received April 3, 2026

    Report

    Report Number
    3005075853-2026-02449
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    January 27, 2025
    Report Date
    April 13, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/2/2026. 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: 4/13/2026. CORRECTED DATA: B1, B2, 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? IF YES, PLEASE EXPLAIN. THE FINDINGS REPORTED ARE ALL DUE TO RECURRENT MALIGNANCY AFTER RESECTION AND HAVE NO RELATIONSHIP TO THE USE OF THE DEVICE. 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: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MACCIÒ A, VALLERINO V, SOLE G, NEMOLATO S, GIGLIO E, MADEDDU C. SUCCESSFUL LAPAROSCOPIC CYTOREDUCTIVE SURGERY FOR MULTIPLE (THREE) ADVANCED RECURRENCES OF AGCT IN A YOUNG WOMAN. A CASE REPORT. INT J SURG CASE REP. 2025 FEB;127:110960. DOI: 10.1016/J.IJSCR.2025.110960. EPUB 2025 JAN 27. PMID: 39874807; PMCID: PMC11808675. THIS IS A CASE STUDY OF 34-YEAR-OLD WOMAN, WHO HAD A RIGHT ADNEXECTOMY FOR AGCT (ADULT GRANULOSA CELL TUMORS) IN 2020 WAS REFERRED WITH AN 8- MONTH HISTORY OF A LARGE LEFT OVARIAN CYST AND AMENORRHEA. THE PATIENT UNDERWENT TOTAL LAPAROSCOPIC SURGERY, INCLUDING RADICAL TYPE A HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, PELVIC PERITONECTOMY, TOTAL MESORECTAL EXCISION, TOTAL OMENTECTOMY, AND PELVIC AND LUMBO-AORTIC LYMPHADENECTOMY USING ECHELON FLEX¿, ETHICON/JOHNSON & JOHNSON, CINCINNATI, OH, USA). REPORTED COMPLICATIONS ARE N=1; 34-YEAR-OLD FEMALE -REVEALED HIGH METABOLIC ACTIVITY IN THE LEFT ILIAC FOSSA AND A LARGE NON-SPECIFIC POSITIVE ACTIVITY IN THE RIGHT PELVIS -PELVIC LYMPH NODE RECURRENCE AND POSSIBLE SMALL INTESTINE INVOLVEMENT TREATMENT: LAPAROSCOPY AND PERITONECTOMY -AFTER A FOLLOW-UP OF 10 MONTHS FROM SECONDARY CYTOREDUCTIVE SURGERY, A PET/ CT SHOWED SUSPECTED ABDOMINAL HYPERMETABOLIC AREAS. THEN, A TERTIARY DIAGNOSTIC/OPERATIVE LAPAROSCOPIC SURGERY SHOWED A MILIARIFORM PERITONEAL CARCINOMATOSIS: A PERITONECTOMY WAS PERFORMED IN CONCLUSION, THIS CASE REPORT PRIMARILY FOCUSES ON A PERSONALIZED TREATMENT APPROACH THAT REPLACES OPEN SURGERY AND TRADITIONAL POSTOPERATIVE CHEMOTHERAPY WITH MULTIPLE LAPAROSCOPIC PROCEDURES FOR PATIENTS WITH RECURRENT OVARIAN GRANULOSA CELL TUMORS (AGCTS). THIS INNOVATIVE METHOD OFFERS NEW INSIGHTS FOR SIMILAR CASES. HOWEVER, DUE TO LIMITATIONS IN PATIENT DATA, THE CLINICAL IMPLICATIONS OF THE REPORT REQUIRE FURTHER INVESTIGATION. THIS APPROACH CONSIDERS THE PATIENT'S PROFESSIONAL NEEDS AND PREFERENCES, ENABLING HER TO MAINTAIN A HIGH QUALITY OF LIFE AFTER SURGERY WHILE ACHIEVING FAVORABLE SURVIVAL OUTCOMES. OUR WORK EMPHASIZES THE IMPORTANCE OF SYSTEMATICALLY EXPLORING THE ROLE OF MINIMALLY INVASIVE SURGERY IN COMPLEX CASES OF ADVANCED OR RECURRENT AGCTS. THIS PERSPECTIVE IS SUPPORTED BY OUR CASE, OTHER CASE REPORTS, AND THE LIMITED CLINICAL SERIES AVAILABLE IN THE LITERATURE. HTTPS://JNJ-ECM-PROD.MY.SALESFORCE.COM/SFC/P/41000000CFJ2/A/VY000009GPXU/MM1S6ESJP6A.SGFCOWWLEBS_BZHMNQOBSBTTQZH7CLO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29612 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention