BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 57104 · Received September 20, 1996

    Report

    Report Number
    1527736-1996-00109
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Date of Event
    August 7, 1996
    Report Date
    September 6, 1996
    Manufacturer
    NA
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE FROM A FT050 KIT WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE EZ35W WOULD NOT LOCK DOWN. THE DEVICE WAS FINALLY CLOSED AND THE SURGEON DID FIRE IT. THE STAPLER MISFIRED. ANOTHER EZ35W WAS OPENED TO COMPLETE THE CASE. NO BUTTRESSING MATERIAL. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER LINEAR CUTTER GAG NA NA H40177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other