BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA

    MDR report key: 21356812 · Received February 11, 2025

    Report

    Report Number
    2647580-2025-00491
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    September 8, 2009
    Report Date
    February 11, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GAG
    PMA / PMN Number
    K221003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 IME E2402: LABS ABNORMAL FOR WBC; HEMOGLOBIN; HEMATOCRIT; BLOOD UREA NITROGEN, FREE AIR 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

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A ROUX-EN-Y GASTRO JEJUNOSTOMY. DURING A SUBSEQUENT SURGERY A LEAK WAS FOUND AT GASTROJEJUNOSTOMY ANASTOMOSIS INDICATING A STAPLE LINE LEAK. IT WAS REPORTED THAT AFTER THE SURGERY, THE PATIENT EXPERIENCED CRAMPY ABDOMINAL PAIN, ABSCESS, LABS ABNORMAL FOR WBC; HEMOGLOBIN; HEMATOCRIT; BLOOD UREA NITROGEN, POLYMICROBIAL ABDOMINAL WOULD INFECTION WITH KLEBSIELLA; NON-HEMOLYTIC STREP; PEPTOSTREPTOCOCCI, FREE AIR, MULTIPLE FLUID COLLECTIONS, GJ ANASTOMOSIS LEAK, ACUTE BLOOD LOSS ANEMIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED HOSPITALIZATION, IV FLUIDS, ANTIBIOTICS, NPO, EXPLORATORY LAP, DRAINAGE OF INTRA-ABDOMINAL ABSCESS, WASHOUT, DRAIN PLACEMENT, EGJ WITH STENT PLACEMENT TO COVER LEAK ON BOTH SIDES, FLUOROSCOPY USED TO CONFIRM LEAK, CT SCAN, ESOPHAGOSCOPIES, ESOPHAGEAL STENT READJUSTMENT, PICC LINE PLACEMENT, PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836436 EEA STAPLER, SURGICAL GAG US SURGICAL PUERTO RICO EEA25

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R