BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER

    MDR report key: 6212276 · Received December 29, 2016

    Report

    Report Number
    6212276
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ETHICON ENDOSURGERY LLC
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SET UP FOR A ROBOTIC NEPHRECTOMY. DURING THE PROCEDURE, THE STAPLER WAS USED. WE REMOVED THE STAPLER AND AFTER THAT IT WAS NOTED THAT THERE WAS VERY FAST BLEEDING FROM THE SITE WHERE THE STAPLE FIRED. IT APPEARS THAT THE STAPLER MISFIRED, WHICH IS LEADING TO BLOOD LOSS. IT WAS DIFFICULT TO VISUALIZE AT THAT TIME TO REPAIR THE VASCULAR INJURY. THEREFORE, WE DID CONVERT IT TO AN OPEN PROCEDURE AND THE VASCULAR SURGEON WAS CALLED. CARDIAC THORACIC SURGEON PROVIDED ASSISTANCE DURING THE CASE. CARDIAC SURGEON PERFORMED EMERGENT SALVAGE REPAIR OF THE LACERATION TO THE ABDOMINAL AORTA AND VENOPLASTY OF THE INFERIOR VENA CAVA WITH RESECTION REMOVAL OF RENAL CELL CARCINOMA FROM THE LEFT RENAL VEIN, VERIFICATION OF DISTAL ARTERIAL PERFUSION. THE PATIENT DID LOSE 2 LITERS OF BLOOD AND THREE UNITS OF PACKED RED BLOOD CELLS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862039 POWER PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC ACCESSORY OCW ETHICON ENDOSURGERY LLC PLEE60A N92C67

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other DAVINCI ROBOT| NO OTHER THERAPIES