BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3243667 · Received July 23, 2013

    Report

    Report Number
    0002090040-2013-00010
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NEVER RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR AN EVALUATION. THE DEVICE WAS RESTERILIZED THOUGH OUR OPEN-BUT-UNUSED PROGRAM WHERE THE DEVICE IS JUST REPACKAGED AND RESTERILIZED. NO FUNCTION TESTING IS PERFORMED. A REVIEW OF THE OM WEBSITE WAS REVIEWED AND INDICATES THE PART NUMBER AND DESCRIPTION (INCLUDING SIZE DESCRIPTION) ARE CORRECT WITH REFERENCE TO ONE ANOTHER; THEREFORE, IT IS INTERPRETED THE REPORTED ISSUE IS INDICATING THE PHYSICAL DEVICE DOES NOT MATCH THE LABELED SIZE DESCRIPTION. THE COMPLAINT WAS NOT CONFIRMED FOR THE REPORTED FAILURE MODE RELATED TO MISLABELING AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE MAY BE LINKED TO A MIX-UP OF LABELS OR IDENTIFICATION ERROR DURING THE MANUFACTURING PROCESS (I.E. PROCESSING ERROR), USER INTERPRETATION, OR MIX-UP AT THE FACILITY. THE COMPLAINT WAS ALSO NOT CONFIRMED FOR THE REPORTED FAILURE MODE RELATED TO THE FUNCTIONALITY OF THE DEVICE AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE MAY BE LINKED TO A PROCESSING ERROR (INCLUDING INSPECTION ERROR), MISHANDLING PRIOR/SUBSEQUENT TO DISTRIBUTION, USER ERROR, OM DEFECT, OR ANCILLARY EQUIPMENT ERROR. THE MAUDE DATABASE INDICATES ONE REPORT RELATED TO THE FAILURE MODE AT HAND; BASED ON THE INFREQUENCY OF THIS EVENT, IT IS UNLIKELY THE ROOT CAUSE IS RELATED TO AN OEM DEFECT. BASED ON THE PROVIDED MATERIALS, NONE OF THESE POTENTIAL ROOT CAUSES (EXCLUDING OM DEFECT) CAN BE RULED OUT. 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 DURING A PROCEDURE THE STAPLER "DID NOT RELEASE." IT WAS ALSO REPORTED THAT THE "DEVICE SIZE WAS WRONG ON THE PACKAGING." THE PROCEDURE TIME WAS EXTENDED AN HOUR AND A HALF AND THE PATIENT WAS SENT TO THE ICU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLER "DID NOT RELEASE." IT WAS ALSO REPORTED THAT THE "DEVICE SIZE WAS WRONG ON THE PACKAGING." THE PROCEDURE TIME WAS EXTENDED AN HOUR AND A HALF AND THE PATIENT WAS SENT TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343803 NA GDW GDW STRYKER SUSTAINABILITY SOLUTIONS PHOENIX EEAORVIL21 839405U

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization