The customer informed olympus, the physician and operator had extensive burning to their eyes after trying to load acecide-c bottles into the subject device.The bottles would not fit and when closing the drawer, the bottles leaked and caused excessive fumes.The physician was informed by olympus to remove eye contact lenses and flush with copious amounts of water.A request for additional information is in progress.This event includes 2 reports as follows: (b)(6) is for the physician exposed to the chemicals, with burning eyes.(b)(6) is for the operator exposed to the chemicals, with burning eyes.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, although the working status of the operator during the bottle replacement is unknown, it is likely that the reported event occurred because the user worked without complete protection of his eyes due to lack of understanding of instructions for use (ifu).The event can be detected/prevented by following the ifu which state: ¿chapter 2 nomenclature and functions: 2.8 consumable accessories (optional) olympus-validated concentrated disinfectant solution (1,065 ml cassette bottles).¿chapter 8 replacement of consumable items: 8.2 replacing the disinfectant solution load the disinfectant solution¿.¿warning: when handling the disinfectant solution, wear appropriate personal protective equipment to prevent direct contact with your skin and eyes or excessive inhalation of its vapor.If any disinfectant solution gets in your eyes, immediately rinse with a large amount of fresh water, and then consult a medical specialist.Wear personal protective equipment, such as eyewear, face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin and eyes is not exposed.All personal protective equipment should be inspected before use and replaced periodically.If personal protective equipment is damaged or defective in anyway, do not handle hazardous chemicals and refer to the facility policies.¿ ¿when using the disinfectant solution and alcohol, olympus recommends the use of gas filters and running this reprocessor in well-ventilated areas.Wear face mask, gloves, and protective clothes to minimize aspiration and skin contact.Wear goggles for eye protection.¿ this supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.
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