BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLINE SURGICAL INC

    MDR report key: 3820543 · Received May 14, 2014

    Report

    Report Number
    MW5036152
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE MICROLINE LAPAROSCOPIC FENESTRATED GRASPER TIP TO RETRACT THE GALLBLADDER. THE GRASPER BROKE IN HALF CAUSING A PIECE OF METAL TO BECOME LOOSE IN THE PTS ABDOMEN. THE SURGICAL TEAM RETRIEVED THE BROKEN FRAGMENT AND C-ARM WAS USED TO VISUALIZE ABDOMEN FOR ANY OTHER METAL FRAGMENTS. THE C-ARM AND CHEST X-RAY POST OP WERE BOTH CLEAR. THE FAMILY WAS NOTIFIED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288317 MICROLINE SURGICAL INC RENEW LAPAROSCOPIC FENESTRATED GRASPER FORCEP TIPS GEI MICROLINE SURGICAL INC 00116955
    288378 MICROLINE SURGICAL INC RENEW LAPAROSCOPIC FENESTRATED GRASPER FORCEP TIPS GEI MICROLINE SURGICAL INC 3222 00116277

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention