BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD ECHELON

    MDR report key: 5853510 · Received August 8, 2016

    Report

    Report Number
    3005075853-2016-04430
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Report Date
    July 21, 2016
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT DEVICE WAS USED WITH THE ECR45D? NO INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N53036. THE ANALYSIS RESULTS SHOWED THAT ONE ECR45D RELOAD WAS RETURNED UNFIRED AND WITH THE PAN PARTIALLY DETACHED AT PROXIMAL END. UPON FURTHER INSPECTION, IT WAS NOTED THAT 3 DRIVERS WERE MISSING, MAKING THE RELOAD NON-FUNCTIONAL. ONE POSSIBLE CAUSE FOR THE DAMAGE TO THE PAN MAY BE IMPROPER LOADING OF THE CARTRIDGE RELOAD ONTO THE DEVICE. IT SHOULD BE NOTED THAT EACH CARTRIDGE RELOAD IS 100% INSPECTED THROUGH AN AUTOMATED VISION SYSTEM TO ENSURE THAT THE ONE PIECE SLED AND ALL STAPLE DRIVERS ARE PRESENT PRIOR TO SHIPMENT. ALTHOUGH NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE DRIVERS TO FALL, IT IS POSSIBLE THAT THE PACKAGE WAS NOT OPENED USING THE STERILE TECHNIQUE RESULTING IN THE DRIVERS DISLODGING FROM THE RELOAD. IN ADDITION IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CARTRIDGE COULD NOT BE LOADED INTO THE JAW. IT WAS FOUND THAT THE CARTRIDGE PAN GOT DISTORTED AND ALSO THE SLED CAME OFF. NO PIECES FELL INTO THE PATIENT. ANOTHER CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505127 GOLD RELOAD ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1