BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA

    MDR report key: 21452897 · Received February 24, 2025

    Report

    Report Number
    2647580-2025-00615
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    October 3, 2022
    Report Date
    March 11, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GAG
    PMA / PMN Number
    K231491
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 IME E2402: ELEVATED TROPONIN, SOMNOLENCE, LABS ABNORMAL FOR HEMOGLOBIN; HEMATOCRIT; WBC, TUBULAR TRACT, HEMODYNAMICALLY UNSTABLE, FREE GAS IN ABDOMEN/PELVIS, CRITICALLY ILL 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: REMOVED H6 IME E2402: CRITICALLY ILL. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDED H6 (PATIENT CODES, REMOVED & ADDED IME E2402: SOMNOLENCE & AGITATION). 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. 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 LOOP ILEOSTOMY CLOSURE. IN THE INITIAL SURGERY THE ILEOSTOMY WAS SEPARATED FROM SURROUNDING TISSUE AND A DOUBLE ANASTOMOSIS WAS PERFORMED. DURING A SUBSEQUENT SURGERY IT WAS FOUND THAT THERE WAS A DISRUPTION OF THE ILEOSTOMY CLOSURE WITH INTRAABDOMINAL CONTAMINATION FROM AN ANASTOMOTIC LEAK. WHICH INDICATED A STAPLE LINE LEAK CAUSED BY THE STAPLER FAILING TO CREATE A LASTING SEALED ANASTOMOSIS DUE TO THE STAPLER TRANSECTING THE TISSUE BUT NOT PROPERLY DEPLOYING THE STAPLES. IT WAS REPORTED THAT AFTER USAGE OF THE DEVICE, THE PATIENT EXPERIENCED DEFECTIVE DEVICE, LIFE-TREATING INJURIES, LETHARGY, ABDOMINAL PAIN, LOW BLOOD PRESSURE, CRITICALLY ILL, MULTIFOCAL AREAS OF FREE FLUID/LOCULATED GAS IN THE ABDOMEN PELVIS, BOWEL PERFORATION, ABSCESSES, SEPTIC SHOCK, ANEMIA, EMOTIONAL HARM, PERMANENT INJURIES, EMOTIONAL DISTRESS, BLEEDING, SEPSIS, LOSS OF ENJOYMENT OF LIFE, PAIN, SUFFERING, MENTAL ANGUISH, FEAR, MENTAL PAIN, DISFIGUREMENT, DISABILITY, DIZZINESS, HYPOTENSION, RIGHT LEG PAIN, ABNORMAL EKG, BILATERAL PLEURAL EFFUSIONS, LABS ABNORMAL FOR HEMOGLOBIN; HEMATOCRIT; WBC, ULCERATION MARKED ACUTE SEROSITIS AT PRIOR ANASTOMOTIC SITE, TUBULAR TRACT, FECAL DEBRIS IN MID ABDOMINAL REGION, HEMATOMA, SEROMA, ELEVATED TROPONIN, DEMAND ISCHEMIA IN SETTING OF END-STAGE RENAL DISEASE, HYPERKALEMIA, DEH YDRATION, SOMNOLENCE, AGITATION, HYPOGLYCEMIA, INTRAABDOMINAL INFECTION, HEMODYNAMICALLY UNSTABLE, PERITONITIS, ADHESIONS, ENTEROTOMY, SAD MOOD, ACUTE HYPOXIC RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE WITH MILD INTERSTITIAL EDEMA, POOL OF BLOOD COMING FROM COLOSTOMY BAG, PATIENT COMPLAINED OF THE ROOM SPINNING, FEELING WEAK, MILDLY PALE; LIQUID BLACK DISCHARGE FROM STOMA BLEEDING, ULCER WITH FRESH BLOOD IN TIP OF BULB OF DUEODENUM, CLOTTING, HEMORRHAGIC SHOCK, ACUTE BLOOD LOSS ANEMIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL REPAIR SURGERIES, MULTIPLE HOSPITALIZATIONS, ICU, CT SCAN, EXPLORATORY SURGERY, EXPLORATORY LAP, LYSIS OF ADHESIONS, RESECTION OF THE ILEOSTOMY CLOSURE, RECREATION OF THE ILEOSTOMY LEAVING THE PATIENT WITH A PERMANENT STOMA, X-RAY, BLOOD TRANSFUSION, PALLIATIVECARE, RESECTION OF PREVIOUS ANASTOMOSIS, EKG, IV FLUID, LIQUID DIET, PAIN MEDICATION, TRIPLE IV ANTIBIOTICS, NG TUBE, ATIVAN, ABDOMINAL WASHOUT, ENTEROTOMY CLOSED WITH SUTURE, EXTUBATED, WOUND VAC, PSYCHIATRY CONSULT, ORAL ANTIBIOTICS, PICC LINE PLACEMENT, NOREPINEPHRINE DRIP, ENDOSCOPY, ULCER INJECTED WITH EPINEPHRINE, PLACEMENT OF CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521418 TA STAPLER, SURGICAL GAG US SURGICAL PUERTO RICO TA6035S

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Life Threatening| R| S| H PRODUCT ID - GIA8038S, LOT # - UNK