BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS FLEX45 K

    MDR report key: 3172908 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03067
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE EVENT STATES THAT THE DEVICE WAS HARD TO OPEN HOWEVER AT ANALYSIS THE PACKAGE WAS NOTICED TO BE RIPPED AND NOT OPENED. HOW DID THE PACKAGING BECOME RIPPED? RELATED TO THE WAY THE PACKAGING BECAME RIPPED, WE WERE NOT ABLE TO OBTAIN MORE DETAILS FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT INDICATED THAT THERE WERE DIFFICULTIES TO OPEN THE TYVEK. THE RETURNED PACKAGE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE PACKAGE WAS SEALED AND HAD NOT BEEN OPENED. PACKAGE SEAL WAS INTACT AND NO DELAMINATION WAS PRESENT. A HOLE WAS CONFIRMED PRESENT IN THE MIDDLE OF THE PACKAGE OVER A SMOOTH PART OF THE DEVICE AND NOT OVER ANY PROTRUDING COMPONENT. AN INK CIRCLE WAS DRAWN ON THE TYVEK AROUND THE DAMAGE. THE TRIANGULAR-SHAPED HOLE, OR RIP, WAS FROM THE OUTSIDE AND THE TYVEK WAS BUNCHED UP AROUND THE SNAG. REVIEW OF THE BATCH HISTORY RECORD FOUND THE BATCH WAS NOT REWORKED NOR HAD ANY ADDITIONAL HANDLING OUTSIDE THE NORMAL PACKAGING PROCESS THAT WOULD HAVE RESULTED IN THE GROSS DAMAGE CONSISTENT WITH THIS PACKAGE. PRODUCT IS 100% VISUALLY INSPECTED PRIOR TO RELEASE AND DAMAGE OF THIS MAGNITUDE WOULD MOST LIKELY HAVE BEEN IDENTIFIED AS PART OF THE INSPECTION. IT IS MOST LIKELY THAT THE PACKAGE WAS DAMAGED EXTERNAL TO THE PACKAGING FACILITY POSSIBLY THROUGH MISHANDLING OF THE PACKAGE. IT IS ALSO POSSIBLE THAT THE DAMAGE OCCURRED IN TRANSIT FROM THE CUSTOMER TO ANALYSIS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WERE DIFFICULTIES TO OPEN THE TYVEK. NOT USED ON PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273574 ENDOPATH** ETS FLEX45 K STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H44V6E

    Patients

    Seq Age Sex Outcome Treatment
    1