BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNUSED MANUFACTURED PRODUCT

    MDR report key: 3771558 · Received April 24, 2014

    Report

    Report Number
    0002090040-2014-00020
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOTE RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. AS THERE WAS NO DEVICE RETURNED, DEVICE INSPECTION COULD NOT BE PERFORMED. THE COMPLAINT WAS NOT CONFIRMED FOR THE REPORTED FAILURE MODE. THE ROOT CAUSE OF THE FAILURE MODE IS UNKNOWN; HOWEVER, POSSIBLE ROOT CAUSES MAY BE LINKED TO THE FOLLOWING: MISHANDLING PRIOR/SUBSEQUENT TO DISTRIBUTION FROM STRYKER, PROCESSING ERROR, RECEIVED TO STRYKER IN NON-WORKING CONDITION AND/OR AN OM DEFECT. SINCE THE REPORTED COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION NONE OF THE ABOVE POTENTIAL ROOT CAUSES MAY BE EXCLUDED. THIS REPORT WAS FILED DUE TO A HISTORY OF INJURY ASSOCIATED WITH THE REPORTED ISSUE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION HAS NOT YET BEEN COMPLETED FOR THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMATE PULS PX SKIN STAPLER IS "MISFIRING, GETTING CLOGGED, AND IS COMING BACK TO THE FACILITY WITH LESS STAPLES." THERE WERE NO ADVERSE CONSEQUENCES REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMATE PULS PX SKIN STAPLER IS "MISFIRING, GETTING CLOGGED, AND IS COMING BACK TO THE FACILITY WITH LESS STAPLES." THERE WERE NO ADVERSE CONSEQUENCES REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248729 UNUSED MANUFACTURED PRODUCT STAPLER, SURGICAL GAG STRYKER SUSTAINABILITY SOLUTIONS PHOENIX PXW35 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1