BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2884148 · Received December 21, 2012

    Report

    Report Number
    1056128-2012-00149
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    GEI
    PMA / PMN Number
    K012625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME A DEVICE INVESTIGATION HAS BEEN STARTED BUT NOT YET COMPLETED. ONCE THE DEVICE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING TO OPEN THE LAPAROSCOPIC SCISSORS FOR SURGERY DURING PRE-OP SET UP "BLACK DEBRIS WAS FOUND INSIDE THE SEALED PACKAGING." THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A GEI GEI STRYKER SUSTAINABILITY SOLUTIONS 5DCS 2218270

    Patients

    Seq Age Sex Outcome Treatment
    1