BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR SLEEVE

    MDR report key: 5737822 · Received June 16, 2016

    Report

    Report Number
    MW5062928
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 16, 2016
    Manufacturer
    APPLIED MEDICAL DISTRIBUTION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TROCAR WAS USED TO ASSIST WITH ROBOTIC ASSISTED LAPAROSCOPIC VENTRAL HERNIA REPAIR. WHEN THE SCRUB TECH INSERTED THE MESH THROUGH THE PORT, A PIECE OF THE TROCAR BROKE OFF INTO THE PATIENT'S ABDOMEN. THE PIECE WAS REMOVED WITH THE TROCAR. STAFF DID NOT SAVE THE PACKAGING FOR SPECIFIC LOT #, BUT THERE ARE 6 POSSIBLE LOT #'S: 1232066, 1259880, 1240711, 1237986, 1225198, 1237515.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384714 TROCAR SLEEVE TROCAR SLEEVE GCJ APPLIED MEDICAL DISTRIBUTION 1232066

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR