BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3150295 · Received June 6, 2013

    Report

    Report Number
    0001056128-2013-00088
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLM
    PMA / PMN Number
    K062497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE LOT NUMBER AND SERIAL NUMBER ARE UNKNOWN SO THE MANUFACTURE DATE AND EXPIRATION DATE ARE NOT AVAILABLE. POTENTIAL CAUSES OF THE REPORTED ISSUE WERE DETERMINED TO BE EITHER DEFORMATION OF THE SEALS DUE TO CLINICAL USE; OR BASED ON THE INFORMATION PROVIDED IN THE IFU, THE FAILURE MAY HAVE OCCURRED AS A RESULT OF USING AN INSTRUMENT WITH A DIAMETER SMALLER THAN THE TROCAR. SSS'S INSTRUCTIONS FOR USE STATES: ¿USING AN INSTRUMENT WITH A DIAMETER SMALLER THAN THE TROCAR MAY RESULT IN DESUFFLATION OF THE BODY CAVITY.¿ THIS IS THE FIRST COMPLAINT OF THIS NATURE THAT SSS HAS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE "THE PORTS WERE LEAKING" ON THE TROCAR. SURGISEAL WAS USED TO STOP THE BLEEDING WHILE ANOTHER TROCAR WAS OBTAINED TO REPLACE THE DEVICE. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251302 NA NLM NLM STRYKER SUSTAINABILITY SOLUTIONS LAKELAND CB12LT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1