BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS FOCUS 17 CM CURVED SHEAR

    MDR report key: 2133506 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02474
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS ADDITIONAL INFO: PT. HAD BLEEDING ONE THE GASTRO EPIPLOIC (SEALED WITH HARMONIC) ON J8 AND ON SHORT ARTERIES COMING FROM THE MESENTERIC ON J14. TWO DIFFERENT PLACES WHERE BLOOD WAS LOST. ON J14, THE PATIENT LOST AROUND 2 LITER OF BLOOD IN 25 MINUTES, HE IS NOW FINE. THE SURGEON CONFIRMED HIS PATIENT WAS NOT AN EASY CASE SINCE HE HAD CHEMOTHERAPY FOR A CARCINOMA, WAS TAKING HEPARIN AND HAD HYPOALBUMIN. HE WAS NOT CARDIAC AND HAD NOT INFECTION WHEN HE RETURNED IN THE OR. [HYPOALBUMINEMIA IS A MEDICAL CONDITION WHERE LEVELS OF ALBUMIN IN BLOOD SERUM ARE ABNORMALLY LOW. IT IS A SPECIFIC FORM OF HYPOPROTEINEMIA.] SURGEON SAID PATIENT IS TAKING LOVENOX 40 MG BECAUSE OF THROMBOPROPHYLAXY. NO INFORMATION PROVIDED IF PATIENT HAD STOPPED USE OF HEPARIN PRIOR TO SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INITIAL PROCEDURE (GASTRIC BYPASS) TOOK PLACE ON (B)(6) 2011. THERE WERE NO ISSUES DURING THE PROCEDURE, BUT THE SURGEON HAD A HEMOSTASIS INCIDENT ON THE STOMACHIC ARTERY. THE HEMOSTASIS DROPPED, THE BLEEDING WAS IMMEDIATELY CONTROLLED BY THE SURGEON. THE SURGEON FINISHED THE PROCEDURE WITHOUT FURTHER ISSUE. SEVEN DAYS AFTER THE INITIAL PROCEDURE ((B)(6) 2011), THE PATIENT HAD A SUDDEN DROP IN BLOOD PRESSURE IN THE INTENSIVE CARE UNIT. THE PATIENT WAS IMMEDIATELY RE-OPERATED. THE SURGEON NOTICED THAT THERE WAS BLEEDING FROM THE EPIPLOIC ARTERY. THE SURGEON MADE A MANUAL SUTURE, THE PATIENT RECEIVED AROUND 6 LITERS OF BLOOD DURING THE PROCEDURE. ON (B)(6) 2011, WHEN THE PATIENT SEEMED FINE AFTER THE 2ND PROCEDURE, THE SURGEON POINTED OUT THAT THE PATIENT HAD LOST AROUND 1,5 LITERS OF BLOOD WITH BLOOD CLOTS AND HAD A NEW DROP IN BLOOD PRESSURE. THE PATIENT WAS IMMEDIATELY RE-OPERATED. THE SURGEON NOTICED THAT THE HEMOSTASIS HAD FAILED ON A COLLATERAL ARTERY ON THE MESENTERY OF THE SMALL INTESTINE. HE MADE A MANUAL SUTURE. THE PATIENT RECEIVED AROUND 2 LITERS OF BLOOD DURING THE PROCEDURE. THE PATIENT WAS ACTUALLY IN THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS FOCUS 17 CM CURVED SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK H4349P

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE