BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3883607 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04116
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PRODUCT WAS RECEIVED WITH CRACKED FLANGES AND DENTS ON THE BLISTER. THE SAMPLES WERE INSPECTED AND FOUND TO HAVE COMPRESSED END RAILS ON THE ENDS OF THE CARTONS IN ADDITION TO BLISTER DAMAGE. THE CARTON WAS DAMAGED FROM SUSPECTED DROP. THE BLISTER FLANGES WERE CRACKED AROUND THE EDGES, BUT DID NOT CAUSE A BREACH TO THE STERILE BARRIER OF THE PACKAGE. THE DAMAGE OBSERVED IS INDICATIVE OF DAMAGE THAT WOULD OCCUR FROM AN END DROP IN THE PACKAGE, CONFIGURATIONS WORST CASE ORIENTATION. THE INDENTATIONS ON THE BLISTER IS DIRECTLY ALIGNED TO THE PROXIMAL END OF THE DEVICE WHERE THE BATTERY IS SEATED, WHICH WOULD INDICATE SIGNIFICANT FORCE HAD BEEN APPLIED TO THE PACKAGE, ALLOWING THE DEVICE TO PUSH AGAINST THE END OF THE BLISTER, FORMING THESE DENTS. THE BLISTER MANUFACTURER (PRENT) WAS REFERENCED TO REVIEW AND IT WAS DETERMINED THAT IT HAD NOT BEEN DESIGNED INTO THE PACKAGING CONFIGURATION, AND WAS IN FACT OBTAINED THROUGH DROPS AFTER THE BLISTER HAD BEEN PACKED OUT. THE COMBINED EVIDENCE OF A.) CRUSHED CARTON END RAILS, B.) BLISTER DENTING DAMAGE FROM DEVICE CONTACT AND C.) BLISTER FLANGE CRACKING SUGGESTS THAT THE PACKAGES EXPERIENCED AN EVENT THAT WOULD BE REPRESENTATIVE OF A DROP IN THE WORST CASE ORIENTATION, FROM AN EXTREME HEIGHT BEYOND THAT CHALLENGED DURING THE HAZARD SIMULATION TESTING. IT IS SUSPECTED THAT THE DAMAGE OCCURRED EXTERNAL TO THE PACKAGING FACILITY. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    JJKK RECEIVED THE PRODUCT(S) AND DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS THREE OUT OF SIX PACKAGES HAS BEEN DAMAGED(CRACK). SALES CARTON FOR DEVICE A AND B WAS CRUSHED BUT NO OTHER DEFECT WAS FOUND AT ITS SHIPPER BOX. ALSO, NO DEFECTS ARE FOUND AT SHIPPER BOX AND SALES CARTON FOR DEVICE C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359976 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EG35

    Patients

    Seq Age Sex Outcome Treatment
    1