BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD FOR ECHELON

    MDR report key: 2982243 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00898
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SURGEON IS VERY EXPERIENCED, BUTTRESSING MATERIAL, SEAMGUARD, WAS USED. NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION AVAILABLE. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). A VIDEO OF THE PROCEDURE WAS RECEIVED. THE FIRST FIRING IS WITH A GOLD CARTRIDGE AND DOUBLE BUTTRESSING MATERIAL ON STOMACH. THE DEVICE WAS CLOSED AT APPROXIMATELY 2 MINUTES AND 26 SECONDS INTO THE VIDEO. THE DEVICE IS FIRED AT APPROXIMATELY 02:55 WITH DEVICE OPENING AT 03:06. THE DEVICE IS REMOVED, THE STAPLE LIVE APPEARS FINE. SOME ADDITIONAL MOBILIZATION OCCURS PRIOR TO THE NEXT FIRING. THE SECOND FIRING ALSO UTILIZES A GOLD STAPLE CARTRIDGE AND DOUBLE BUTTRESSING MATERIAL. THIS FIRING WAS A CONTINUATION OF THE FIRST FIRING. DEVICE IS PLACED AND CLOSED AT APPROXIMATELY 07:23. DEVICE FIRING APPEARS TO START AT 07:49 WITH THE DEVICE OPENED AT 07:58. DEVICE IS REMOVED AND THE STAPLE LINE LOOKS FINE. NO CONCLUSION: COULD BE MADE AS TO WHY "THE MIDDLE PART OF THE STAPLE LINE WAS OPEN" BASED ON THE VIDEO EVIDENCE PROVIDED AND REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BYPASS SURGERY, THE MIDDLE PART OF THE STAPLE LINE WAS "OPEN". THE SURGEON USED BUTTRESS MATERIAL (SEAMGUARD). NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85963 GOLD RELOAD FOR ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1