BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1162275 · Received September 5, 2008

    Report

    Report Number
    8010047-2008-00154
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Report Date
    August 6, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FHN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE DEVICE WAS EXTENSIVELY CONTAMINATED WITH BIOMATERIAL, WHICH LIMITED THE EVAL TO VISUAL INSPECTION ONLY. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF THE BROKEN SLIDER DUE TO A DETACHED OPERATING PIPE. THERE WAS A SEVERE COMPRESSION KINK NOTED ON THE DISTAL END OF THE TUBE SHEATH, MOST LIKELY CAUSED BY EXCESSIVE FORCE. THE CAUSE OF THE USER'S EXPERIENCE WAS ATTRIBUTED TO EXCESSIVE FORCE WHICH DAMAGED THE TUBE SHEATH AND FRACTURED THE SLIDER OPERATING PIPE. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC POLYPECTOMY, THE SPRING IN THE SLIDER SNAPPED AND THE USERS COULD NOT CONTROL THE CLOSING MECHANISM OF THE POLYLOOP. THE USER FACILITY REPORTED TO HAVE CUT THE CATHETER, REMOVED THE POLYLOOP, AND UTILIZED ANOTHER SIMILAR, BUT DIFFERENT POLYLOOP TO COMPLETE THE PROCEDURE. THE USER FACILITY HAS BEEN CONTACTED SEVERAL TIMES VIA TELEPHONE AND IN WRITING, BUT HAS PROVIDED NO SIGNIFICANT FURTHER INFO. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORPORATION HX-400U-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK