BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORTE AXP SET 10F/12G 55CM

    MDR report key: 1466351 · Received September 4, 2009

    Report

    Report Number
    2027111-2009-00093
    Event Type
    Other
    Date Received
    September 4, 2009
    Date of Event
    July 8, 2009
    Report Date
    September 4, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THIS SUBJECT DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE AND FAILURE MODE. WE HAVE REVIEWED THE DEVICE HISTORY RECORD OF THIS DEVICE AND FOUND NO DEVIATIONS OR DISCREPANCIES IN OUR STANDARD MANUFACTURING AND TESTING PROCEDURES. AS A RESULT WE ARE CONCLUDING OUR INVESTIGATION AND CLOSING THIS INCIDENT FILE. (B)(4). THIS REPRESENTS OUT INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "THE DOCTOR REPORTED IMPORTANT TROUBLES DURING THE RIGID ENDOSCOPE INSERTION (OLYMPUS) THROUGH THE SHEATH. THE DOCTOR WAS USED TO WORK WITH THE FIRST VERSION OF APPLIED SHEATHS 4/5 YEARS AGO WITHOUT ANY PROBLEM, BUT WITH THE UPDATED VERSION AXP IT SEEMS MUCH MORE DIFFICULT TO INSERT THE ENDOSCOPE. HE REPORTED A HIGH INTERNAL FRICTION WITH THE RISK OF INJURIES TO THE URETERS WITH THE DISTAL EDGE OF THE SHEATH. AN EXTERNAL BODY LITHOTRIPSY WAS PERFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE AXP SET 10F/12G 55CM DQX APPLIED MEDICAL RESOURCES B7286 1067453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention