BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 2843694 · Received October 26, 2012

    Report

    Report Number
    8010047-2012-00359
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 27, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FHN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN OLYMPUS SALES VISITED TO THE USER FACILITY TO PROVIDE A TRAINING ON THE DEVICE. IT WAS REPORTED THAT THE USER FACILITY LIKELY DID NOT PULL THE TUBE SHEATH OF THE DEVICE ALL THE WAY BACK TO THE HANDLE. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS REPORT. THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BECAUSE THE FACILITY DISCARDED THE DEVICE AND OMSC COULD NOT CONFIRM THE PHENOMENON. OMSC REVIEWED THE MANUFACTURING RECORDS OF THE SUBJECT DEVICE AND CONFIRMED THAT THERE WAS NO IRREGULARITY. THE HX-400U-30 INSTRUCTION MANUAL ALREADY STATES; WARNINGS: WHEN REMOVING THE HOOK FROM THE LOOP, CONFIRM ON THE ENDOSCOPIC IMAGE THAT THE COIL SHEATH IS EXTENDED FROM THE TUBE SHEATH. OTHERWISE, THE LOOP MAY GET STUCK INSIDE THE INSTRUMENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN UNCERTAIN ENDOSCOPIC PROCEDURE THE USER SUCCESSFULLY PLACED THE LOOP OVER A POLYP AND TIGHTENED IT USING SUBJECT DEVICE, HOWEVER COULD NOT RELEASE THE LOOP FROM THE SUBJECT DEVICE. NO FURTHER DETAILS WERE PROVIDED INCLUDING OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE LIGATING DEVICE LIGATING DEVICE (POLY LOOP) FHN OLYMPUS MEDICAL SYSTEMS CORPORATION HX-400U-30 23K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK