BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO-STAPLER ITM-40091559 REF# EGIA60AMT-60MM

    MDR report key: 17549554 · Received August 14, 2023

    Report

    Report Number
    MW5144543
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 9, 2023
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH ABDOMINAL PAIN ON (B)(6) AND DIAGNOSED WITH APPENDICITIS. SHE UNDERWENT A LAPAROSCOPIC ROBOTIC APPENDECTOMY (B)(6) 2023 WITHOUT COMPLICATIONS AND WAS DISCHARGED (B)(6) 2023. THE EARLY MORNING OF (B)(6) 2023, SHE RETURNED TO THE EMERGENCY DEPARTMENT WITH C/O (COMPLAINS OF) ABDOMINAL PAIN. SHE HAD BEEN TRANSFERRED FROM ANOTHER FACILITY WHERE CT ABDOMEN SHOWED HEMOPERITONEUM WITH REASSURING ABDOMINAL EXAM. HGB =9.3 (9.6 AT OLH) AND HGB 12.6 ON (B)(6) ORIGINALLY. NO BLOOD GIVEN. REPEAT CT ON (B)(6) 2023 SHOWED IMPROVING HEMOPERITONEUM FROM POSTOPERATIVE HEMATOMA/NO ACUTE PROCESS. NO SURGERY NEEDED, PAIN LESSENED AND PATIENT ABLE TO BE DISCHARGED THIS DAY (B)(6) 2023. SURGEON BROUGHT FORWARD CONCERNS REGARDING CURRENT INTERNAL STAPLING DEVICES UTILIZED FOR PROCEDURES. HE BELIEVES BLEEDING IS OCCURRING WITHIN STAPLING LINE. DEVICES WERE NOT SEQUESTERED AS NO KNOWN PROBLEM AT TIME OF USAGE. REFERENCE REPORT: #MW5144542.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198197 ENDO-STAPLER ITM-40091559 REF# EGIA60AMT-60MM STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN EGIA60/ITM-400 P3A0243

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Hospitalization