BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8789846 · Received July 15, 2019

    Report

    Report Number
    3005075853-2019-20403
    Event Type
    Injury
    Date Received
    July 15, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: PERIRECTAL HAEMATOMA AND HYPOVOLAEMIC SHOCK AFTER RECTAL STAPLED MUCOSECTOMY FOR HAEMORRHOIDS. AUTHOR/S: L. A. HIDALGO GRAU, A. HEREDIA BUDÓ, M. J. FANTOVA , X. SUÑOL SALA. CITATION: INT J COLORECTAL DIS (2005) 20: 471¿472 ; DOI 10.1007/S00384-004-0627-Z. THIS CASE STUDY AIMED TO PRESENT A (B)(6) MALE PATIENT WHO UNDERWENT DAY-CASE SURGERY FOR PROLAPSED HAEMORRHOIDS WITH STAPLED RECTAL CIRCULAR MUCOSECTOMY. THE OPERATION WAS CARRIED OUT UNDER SPINAL ANAESTHESIA WITH THE 33-MM ETHICON HAEMORRHOIDAL CIRCULAR STAPLER (PPH 01 STAPLING GUN, ETHICON ENDOSURGERY, BRACKNELL, UK). THE PATIENT WAS NOT DISCHARGED AND WAS ADMITTED DUE TO SEVERE HYPOGASTRIC PAIN AND WAS NOTED RESTLESS WITH BLOOD PRESSURE FALLEN TO 77/55 MMHG AND HEART RATE OF 100 BPM. ACUTE BLEEDING WAS CONFIRMED BY A DECREASE IN THE HAEMOGLOBIN BLOOD LEVELS (POSTOP 78 G/L FROM 155 G/L). COMPUTED TOMOGRAPHY SHOWED A HUGE EXTRAPERITONEAL PERIRECTAL HAEMATOMA. A CONSERVATIVE APPROACH WAS DECIDED UPON; FOUR CONCENTRATES OF RED BLOOD CELLS WERE ADMINISTERED OVER 24 H AND THE PATIENT WAS LEFT ON INTRAVENOUS ANTIBIOTICS (GENTAMICIN 240 MG/24 H I.V. PLUS METRONIDAZOLE 500 MG/8 H I.V.) FOR A WEEK. THE PATIENT WAS STARVED FOR THE SAME PERIOD OF TIME AND HYPOCALORIC PERIPHERAL PARENTERAL NUTRITION WAS ADMINISTERED. FROM THAT TIME ON, HE HAD AN UNCOMPLICATED HOSPITAL STAY AND WAS DISCHARGED 12 DAYS AFTER SURGERY. ONE YEAR LATER, THE PATIENT IS ASYMPTOMATIC, WITH A HAEMOGLOBIN LEVEL OF 140 G/L AND A CTSCAN SHOWING ONLY AN INCREASED DENSITY IN PERIRECTAL FAT. IT IS IMPORTANT TO CONSIDER THE POSSIBILITY OF AN EARLY POSTOPERATIVE PELVIC HAEMATOMA IN A PATIENT WITH UNEXPLAINED ARTERIAL HYPOTENSION AFTER LONGO¿S PROCEDURE. THE CONSERVATIVE APPROACH WAS SUCCESSFUL IN OUR CASE, DUE TO EARLY RECOGNITION OF THE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582526 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1