BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HERNIA STAPLER

    MDR report key: 24334672 · Received February 13, 2026

    Report

    Report Number
    2647580-2026-00359
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    October 6, 2025
    Report Date
    February 13, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VAN HOGEZAND,L.L., GOENSE, L., VAN DER HOEVEN, E.J.R.J., TUTEIN NOLTHENIUS. C.J., VAN OORSCHOT, N., VAN RIEL, L.A.M.J.G., WIEZER, M.J., WIJFFELS, N.A.T.,TAKKENBERG, M., TE RIELE, W.W., DIJKSMAN, L.M., VAN SANTVOORT, H.C., DERKSEN, W.J.M. OPTIMAL USE OF COMPUTED TOMOGRAPHY IN DIAGNOSING INTERNAL HERNIATION AFTER ROUX-EN-Y GASTRIC BYPASS: A PROPOSITION FOR THE APPLICATION OF A RADIOLOGICAL PREDICTION SCORE. OBESITY SURGERY (2025) 35:5136¿5144 HTTPS://DOI.ORG/10.1007/S11695-025-08323-4 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED PATIENTS WHO PRESENTED WITH ABDOMINAL PAIN MORE THAN 30 DAYS POST- ROUX-EN-Y GASTRIC BYPASS SURGERY BETWEEN JANUARY 2014 AND DECEMBER 2019. ENDO UNIVERSAL 65 WAS USED TO CLOSE THE MESENTERIC DEFECTS IN ALL PATIENTS. OF THE 98 PATIENTS WHO PRESENTED WITH PAIN, 44 WERE DIAGNOSED WITH INTERNAL HERNIATION. PATIENTS UNDERWENT COMPUTED TOMOGRAPHY SCAN FOLLOWED BY DIAGNOSTIC LAPAROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393378 UNKNOWN HERNIA STAPLER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN UNKNOWN HERNIA STAPLER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention