BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW LAPAROSCOPIC ENDOCUT SCISSORS TIP

    MDR report key: 3101309 · Received May 3, 2013

    Report

    Report Number
    MW5030078
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GCJ
    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 PATIENT HARM. DATE OF USE: (B)(6) 2013. REASON FOR USE: LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194950 RENEW LAPAROSCOPIC ENDOCUT SCISSORS TIP SCISSOR TIP GCJ MICROLINE SURGICAL, INC. 00111132

    Patients

    Seq Age Sex Outcome Treatment
    1