BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 19031718 · Received April 3, 2024

    Report

    Report Number
    1219930-2024-01420
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 3, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: EGIA60AMT, EGIA60AMT EGIA 60 ARTIC MED THICK SULU (LOT#N3H2255Y); EGIA45AMT, EGIA45AMT EGIA 45 ARTIC MED THICK SULU (LOT#N3G1720Y); EGIAUXL, EGIAUXL ENDOGIA ULTRA UNIV XL STAPLER (LOT#P3E0149). 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 REPORTER, A DAY FOLLOWING A LAPAROSCOPIC SLEEVE GASTRECTOMY FOR OBESITY PROCEDURE, IT WAS FOUND OUT THAT THE PATIENT HAD SHOCK HEMORRHAGIC ON THE STAPLE LINE CLOSE TO THE HYS ANGLE. TO STOP THE HEMORRHAGE, THE PATIENT IMMEDIATELY UNDERWENT ANOTHER SURGERY WHEREIN TWO BLEEDING POINTS WERE VISUALIZED; THE SURGEON THEN USED A CLIP APPLIER TO STOP THE BLEEDING. THIS LED TO 1L BLOOD LOSS AND SEVERE DETERIORATION OF THE PATIENT'S HEALTH STATUS. THE PATIENT WAS GIVEN MULTIPLE BLOOD TRANSFUSIONS AND WAS TAKEN TO THE INTENSIVE CARE UNIT FOR MONITORING. THE PATIENT WAS STABLE SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784214 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other| R