BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW LAPAROSCOPIC ENDOCUT SCISSORS TIP

    MDR report key: 3111479 · Received May 9, 2013

    Report

    Report Number
    MW5030118
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MICROLINE SURGICAL, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SPARK/ARC OF ELECTRICITY WAS NOTED FROM THE LAPAROSCOPIC SCISSORS TIP WHILE DISSECTING THE GALLBLADDER OF THE LIVER BED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204863 RENEW LAPAROSCOPIC ENDOCUT SCISSORS TIP SCISSOR TIP GEI MICROLINE SURGICAL, INC 00111132

    Patients

    Seq Age Sex Outcome Treatment
    1