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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections d4, h6, and h10.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The specific root cause of the reported problem could not be determined at this time because the device was not returned.The following information is stated in the instructions for use (ifu): ¿chapter 4 reprocessing [warning] this instrument was not sterilized before shipment.Before using this instrument for the first time, reprocess it according to the instructions in this chapter.Do not use an instrument that has not been cleaned and sterilized.This poses an infection control risk or can cause tissue irritation.4.1 general policy ¿ the medical literature reports incidents of patient and cross contamination resulting from improper cleaning, disinfection or sterilization.It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national and local hospital guidelines and policies.A specific individual or individuals in the endoscopy unit should be responsible for reprocessing endoscopic equipment.It is highly desirable that a trained backup be available should the primary reprocessing individual(s) be absent.¿ all individuals responsible for reprocessing should thoroughly understand: ¿ your institution¿s reprocessing procedures.¿ occupational health and safety regulations.¿ national and local hospital guidelines and policies.¿ the instructions in this manual.¿ the mechanical aspects of endoscopic equipment.¿ pertinent germicide labeling.Olympus endo-therapy accessories are compatible with 2.0% to 3.2% glutaraldehyde solution.However, routine biological monitoring is not feasible with glutaraldehyde and, therefore, it should not be used to sterilize reusable medical devices that are compatible with other methods of sterilization that can be biologically monitored, such as steam sterilization.[warning] ¿ failure to properly clean and sterilize this instrument after each examination can compromise patient safety.During use, the instrument normally comes in contacts with intact mucous membranes.To minimize the risk of transmitting diseases from one patient to another, after each examination the instrument must undergo thorough manual cleaning followed by sterilization.¿ if the instrument is not cleaned meticulously, effective sterilization cannot be obtained.Clean the instrument thoroughly before sterilization to remove any microorganisms or organic material which can limit the effectiveness of the sterilization process.¿ patient debris and reprocessing chemicals are hazardous.Wear personal protective equipment to guard against dangerous chemicals and infectious material.During cleaning and sterilization, always wear appropriate personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.Always remove contaminated protective clothing before leaving the reprocessing area.¿ the reprocessing procedures described in this manual should be completed the same day the instrument has been used.If reprocessing is delayed, residual organic debris will solidify and it may be difficult to effectively reprocess the instrument.¿ reprocess the instrument immediately after use, first by immersing it in a neutral, low-foaming, medical grade detergent solution, then following the cleaning and sterilization procedures given in this chapter.Failure to reprocess the instrument immediately after use, or using other than a medical-grade detergent may cause corrosion at the metal parts like the grasping jaws.This could impair the operation of the instrument or cause a part of it to break and/or fall off inside the patient.¿ with the cleaning and sterilization methods stated in this instruction manual, prions, which are considered to be the pathogenic substance of the creutzfeldt-jakob disease (cjd) cannot be destroyed or inactivated.When using this instrument on a patient with cjd or variant creutzfeldt-jakob disease (vcjd), be sure to use this product for such patient only and/or immediately dispose of this product after use in an appropriate manner.For methods to handle cjd, please follow the respective guidelines in your country.¿ this instrument is not durable, or does not have sufficient durability against the respective methods stated in the guidelines of each country for destroying or inactivating prions.For information on the durability against each method, please contact olympus.If cleaning and sterilization methods not stated in this instruction manual are performed, olympus cannot guarantee the effectiveness, safety and durability of this instrument.Make sure to confirm that there is no abnormality before use, and use under responsibility of a physician.Do not use if any abnormality is found.4.2 required reprocessing equipment wear the protective equipment as specified in the instructions on page 26.1.Prepare the following equipment.The required amount of detergent solution, lubricant and other equipment depends on the number of instruments to be reprocessed.2.Fill an immersion basin with detergent solution, and fill a second immersion basin with lubricant at the temperature and concentrations recommended by the manufacturers.Also fill the ultrasonic cleaner with detergent solution appropriate for ultrasonic cleaning.Equipment needed for reprocessing: to perform proper reprocessing, the equipment in the following table is required.For details on preparation and directions for use of the following equipment, refer to the respective instruction manuals or contact the equipment manufacturer.Contact olympus for the names of specific brands of detergent solutions and lubricants.Equipment needed protective equipment: appropriate personal protective equipment may include: eye wear, face mask, moisture-resistant clothing, and chemical-resistant gloves.Immersion basin for detergent solution: use a basin with a depth and diameter large enough to allow complete immersion of the instrument when it is coiled in a diameter of not less than 15 cm.Detergent solution for immersion: use a neutral ph, low-foaming, medical grade detergent solution.Ultrasonic cleaner: use a medical grade ultrasonic cleaner with a frequency range of 38 to 47 khz, and with a depth and a diameter large enough to allow complete immersion of the instrument when the insertion portion is coiled in a diameter of not less than 15 cm.Detergent solution for ultrasonic cleaning: use a neutral ph, low-foaming, medical grade detergent solution with no abrasive.Lubricant: use a medical grade water soluble or low-viscosity emulsion type lubricant.Lint-free cloths:- packages for steam sterilization: use packages compatible with steam sterilization (autoclaving).The packages should be large enough to accommodate the instrument when the insertion portion is coiled with a diameter of not less than 15 cm.Sealing device for packages sealing the packages may require a device such as a heat sealer.Prepare an appropriate searling device according to the packages to be used.Autoclave use an autoclave that will operate at the conditions specified in section 4.5, ¿sterilization¿.4.3 cleaning [warning] when cleaning, avoid exposure to the reprocessing chemicals.They may pose an infection control risk or cause skin irritation.[caution] ¿ when reprocessing, not coil the insertion portion in a diameter of less than 15 cm.This could result in damage to the insertion portion.¿ never use excessive force to open or close the instrument.This could damage the instrument.Immersion [warning] immerse the instrument in detergent solution immediately after use.If the instrument is not cleaned immediately, it may be difficult to effectively reprocess and this could result in reduced performance.1.When reprocessing the instrument for the first time after purchase, remove the forceps cap from the grasping jaws and dispose of it.2.Immerse the entire instrument in the detergent solution for the time specified in manufacturer¿s instructions.If no time is specified, immerse for between 5 minutes and 3 hours.3.Remove the instrument from the detergent solution.Ultrasonic cleaning 1.Immerse the entire instrument in the ultrasonic cleaner containing detergent solution.2.Clean ultrasonically for 30 minutes.For details on operation of the ultrasonic cleaner, refer to the instruction manual of the ultrasonic cleaner.3.Remove the instrument from the detergent solution.Rinsing [warning] ¿ after ultrasonic cleaning, rinse the instrument thoroughly to remove residual detergent.Residual detergent solution could cause tissue irritation in the next patient.¿ do not forcefully squeeze, wipe or scrub the instrument.This could cause damage to the instrument or result in reduced performance.1.Rinse the instrument under clean running water.2.Confirm that no debris is left on the surfaces of the instrument.3.Wipe the exterior of the instrument with a clean, dry lint-free cloth.4.4 lubrication [warning] when lubricating, avoid exposure to the lubricant.They may pose an infection control risk or cause skin irritation.[caution] ¿ do not coil the insertion portion in a diameter of less than 15 cm.This could result in damage to the insertion portion.¿ never use excessive force to open or close the instrument.This could damage the insertion portion.1.Immerse the insertion portion in the basin containing lubricant for 2 to 3 seconds.2.Remove the instrument from the lubricant.3.Operate the slider to open and close the grasping jaws two or three times.4.Wipe the exterior of the instrument with a clean, dry lint-free cloth and allow the instrument to air dry.4.5 sterilization sealing the package [warning] before placing the instrument in the package, always close the grasping jaws.Otherwise, it could rupture the package during sterilization or storage and compromise its sterility which could pose an infection control risk or tissue irritation.[caution] ¿ do not coil the insertion portion in a diameter of less 15 cm.This could result in damage to the insertion portion.¿ never use excessive force to open or close the instrument.This could damage the instrument.1.Before sterilization, the instrument must be thoroughly cleaned and dried.Residual moisture inhibits sterilization.2.Coil the insertion portion and place it in the package.Seal the package.For details on sealing, refer to the instruction manual of the package material and the sealing device.Steam sterilization (autoclaving) [warning] ¿ use biological indicators as recommended by your hospital¿s policy and follow the manufacturer¿s instructions, all national and local hospital guidelines and policies.¿ always leave space between the packages in the autoclave.If the packages are placed too close together, effective sterilization will not be possible.¿ allow the sterile package to dry within the autoclave using the autoclave¿s drying cycle (if applicable) or by opening the door of the autoclave and allowing the packages to air dry.Handling a wet package can compromise its sterility.¿ the results of sterilization depend on various factors such as how the sterilized instrument was packed or the positioning, method of placing and loading of the instrument in the sterilization device.Please verify the sterilization effects by using biological or chemical indicators.Also follow the guidelines for sterilization issued by medical administrative authorities, public organizations or the infection management sections at each medical facility, as well as the instruction manual of the sterilization device.1.Place the sealed package containing the instrument in the autoclave and sterilize in accordance with the conditions listed below.For details on operation of the autoclave, refer to the instruction manual for the autoclave or other manufacturer instructions.2.After steam sterilization, let the instrument gradually cool down to room temperature.Sudden changes in temperature may cause instrument damage.[note] autoclavable products have a green model reference label.Products that do not have green model reference labels are not autoclavable.¿ olympus will continue to monitor field performance for this device.
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