BEUDAMED
    FDA Adverse Event Summary report: N

    COVIDIEN-TYCO

    MDR report key: 2688121 · Received May 5, 2009

    Report

    Report Number
    2688121
    Date Received
    May 5, 2009
    Date of Event
    November 20, 2008
    Report Date
    May 1, 2009
    Manufacturer
    COVIDIEN, SURGICAL DEVICES
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, ADMITTED AND TO OPERATING ROOM FOR LAPAROSCOPIC GASTRIC BYPASS. NO DEVICE PROBLEMS WERE NOTED DURING THE PROCEDURE. DISCHARGED FROM THE HOSPITAL TO HOME ON (B)(6) 2008, FOLLOWING UNCOMPLICATED POST-OPERATIVE RECOVERY PROCESS. ON (B)(6) 2008, SEEN IN CLINIC WITH SHORTNESS OF BREATH, C-XRAY REVEALED PULMONARY EFFUSION. ADMITTED TO HOSPITAL FOR EVALUATION, AND ABDOMINAL CT SHOWED AIR FLUID-FILLED ABSCESS ANTERIOR TO THE GASTRIC POUCH AS WELL AS A LARGE ABSCESS AROUND THE SPLEEN. TO OPERATING ROOM FOR EXPLORATION, LAPAROSCOPIC DRAINAGE OF THE TWO INTRAABDOMINAL ABSCESSES AND AN INTRAOPERATIVE ENDOSCOPY. THERE WAS NO OBVIOUS LEAKAGE NOTED IN THE GASTRIC POUCH. THE ENDOSCOPY APPEARED NORMAL WITH NO EVIDENCE OF GJ ANASTOMOTIC LEAK. JP DRAINS WERE PLACED. TO ICU AND REMAINED INTUBATED, (B)(6) 2008, THORACENTESIS. ON (B)(6) 2008, WBC 21,000 AND HGB 8.5. ON (B)(6) 2008, WBC REMAINED 21,000, ALTHOUGH EXTUBATED AND AWAKE. DISCHARGED (B)(6) 2008. ON (B)(6) 2009, RE-ADMIT WITH NEPHROLITHIASIS DISGOSES INCLUDE CHRONIC ABDOMINAL ABSCESS. MOST RECENTLY IN ED (B)(6) 2009, WITH VOMITING. ADDITIONAL COVIDIEN DEVICE USED: TYCO RELOAD STAPLER UNIVERSAL L45 MM X 2.5 MM, TYCO INTRNL EEA XL 34MM ESCPC CIR STACH HD W/TILT DISP...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN-TYCO ENDO GIA ROTICULATOR, ENDO GIA UNIVERSA GDW COVIDIEN, SURGICAL DEVICES

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening UNIVERSAL 12 MM SINGLE USE| TYCO RELOAD STAPLER UNIVERSAL L60 MM X 3.5 MM| ENDO GIA ROTICULATOR 60 - 3.5 SU ENDO GIA| TYCO RELOAD STAPLER UNIVERSAL L12 MM