BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SUSTAINABILITY SOLUTIONS_PRODUCT

    MDR report key: 2971402 · Received February 21, 2013

    Report

    Report Number
    0002090040-2013-00004
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. THE COMPLAINT DEVICE WAS NOT RETURNED TO SSS FOR AN EVALUATION. THE ROOT CAUSE OF THE FAILURE MODE IS UNKNOWN; HOWEVER, POSSIBLE ROOT CAUSES MAY BE LINKED TO THE FOLLOWING: BALLOON DETACHMENT AS A RESULT OF MISHANDLING PRIOR/SUBSEQUENT TO DISTRIBUTION FROM STRYKER (INCLUDES USER STORAGE METHODS). USER ERROR (INCLUDES USER TECHNIQUE AND METHODS). ANCILLARY EQUIPMENT ERROR (INCLUDES ALL OTHER EQUIPMENT OUTSIDE OF THE COMPLAINT DEVICE THAT MAY HAVE CONTRIBUTED TO THE ERROR). THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE BALLOON DETACHED WHILE INSIDE A PATIENT." THE INCISION HAD TO BE WIDENED TO REMOVE THE BALLOON FROM THE BALLOON CATHETER. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77036 UNKNOWN_SUSTAINABILITY SOLUTIONS_PRODUCT GBA EZL STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 16801135 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention