BEUDAMED
    FDA Adverse Event Other Summary report: N

    STLS

    MDR report key: 2001046 · Received February 14, 2011

    Report

    Report Number
    2954339-2011-00001
    Event Type
    Other
    Date Received
    February 14, 2011
    Report Date
    February 8, 2011
    Manufacturer
    STARION INSTRUMENTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE STLS 23C WAS RETURNED, DECONTAMINATED AND INVESTIGATED. THE RETURNED DEVICE WAS IN SATISFACTORY CONDITION, NO COSMETIC ABNORMALITIES WERE OBSERVED. THE RETURNED DEVICE COULD NOT BE INSPECTED FOR ELECTRICAL FUNCTIONING; THE CABLE CONNECTOR WAS CUT OFF. A VISUAL ANALYSIS REVEALED THAT THE COLD BOOT WAS TORN AT THE TIP AREA, CONFIRMING THE COMPLAINT. HOWEVER, IT COULD NOT BE CONFIRMED THAT THE BOOT CAME OFF THE DEVICE; THE TORN BOOT WAS ATTACHED TO THE HINGE THAT CONNECTS BOTH BOOTS TOGETHER AND THE DISTAL TEAR AT THE TIP DID NOT SHOW TO HAVE MISSING BOOT PIECES. A CLOSER LOOK AT THE TORN AREA OF THE BOOT SHOWED THAT THE BOOT MAY HAVE BEEN SHOVED BACK TOWARDS THE PROXIMAL END OF THE JAW. THE BOOTS COULD POTENTIALLY GET DAMAGED IF THE JAWS OF THE DEVICE ARE NOT FULLY CLOSED DURING INSERTION INTO THE CANNULA. IT APPEARS THAT THE BOOT TORE AND PEELED BACKWARDS AS THE DEVICE WAS INSERTED THROUGH THE CANNULA. IT IS UNCLEAR OF HOW THE TORN BOOT HAPPENED, AND WHY THE END USER MENTIONED THAT THE BOOT HAD FALLEN INTO THE PT, THE BOOT IS CLEARLY ATTACHED TO THE HINGE/HOT BOOT.

    Description of Event or Problem · 1

    THE HOSPITAL ORIGINALLY REPORTED THIS COMPLAINT AS A POSSIBLE HANDLE FAILURE ON (B)(6). THE CUSTOMER HAS EXPERIENCED HANDLES SPLITTING APART IN THE PAST. A VISUAL INSPECTION ON (B)(4) 2011 SHOWED THAT THE FAILURE WAS NOT THE HANDLE, PART OF THE WHITE SILICONE TIP HAD BROKEN OFF. THE HOSPITAL CONFIRMED THAT THE WHITE SILICONE TIP WAS INSIDE THE PT AND IT WAS RETRIEVED. ANOTHER STLS WAS OPENED AND THE CASE WAS CONTINUED. NO PT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STLS STLS 23C GEI STARION INSTRUMENTS 102-137D 007012

    Patients

    Seq Age Sex Outcome Treatment
    1