BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLINE SURGICAL ENDOCUT

    MDR report key: 2036057 · Received March 25, 2011

    Report

    Report Number
    2036057
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STERILMED, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A LAPAROSCOPIC SURGERY FOR TAKEDOWN OF ADHESIONS WITH REDUCTION & REPAIR OF CHRONICALLY INCARCERATED VENTRAL HERNIA & SMALL BOWEL RESECTION. THE SLEEVE OF THE SCISSORS TIP THAT COVERS WHERE THE BLADE JOINS THE SHAFT CAME OFF INSIDE OF THE PT. IT WAS FOUND & REMOVED WITHOUT ANY INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLINE SURGICAL ENDOCUT SCISSORS TIP GEI STERILMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR