BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 1912760 · Received December 2, 2010

    Report

    Report Number
    3005075853-2010-06809
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE (B)(4) CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS. THE RELOAD WAS RECEIVED IN GOOD VISUAL CONDITIONS AND FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOADS. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "(B)(6) WANTS TO KNOW IF IS USUAL FOR A STRYKER KNEE TO DISLOCATE MORE THAN ONE TIME. IT KEEPS POPPING OUT AND THE REASON HE WANTS TO KNOW IS BECAUSE THE SURGEON WANTS TO GO IN AND PUT IN A HINGE KNEE BECAUSE THE DOCTOR SAID IF THE HINGE KNEE DOES NOT WORK, HE WILL HAVE TO FREEZE THE KNEE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, ON HAVING DONE THE SECOND EVENT OF SHOTS OF THE SAME RELOAD, IT IS OBSTRUCTED AND THE RAZOR DOES NOT ADVANCE. FOR SUCH MOTIVE ONE DECIDED TO OPEN THE STAPLER TO AVOID TO CRUSH THE STOMACH AND TO USE ANOTHER LOAD. SURGERY WAS PROLONGED FIFTEEN MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TD42

    Patients

    Seq Age Sex Outcome Treatment
    1