MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-ELITE

Device Problem Fitting Problem (2183)

Patient Problem Eye Burn (2523)

Event Date 07/05/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304 - 2022 - 00014.

Event Description

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.

Manufacturer Narrative

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, the reported event was likely occurred because the user worked without complete protection of the eyes due to lack of understanding of the instructions for use (ifu).However, the root cause could not be determined.The event can be detected/prevented by following the ifu which state: ¿nomenclature and functions.Consumable accessories.(optional) olympus-validated concentrated disinfectant solution.(1,065 ml cassette bottles) replacement of consumable items.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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15164521
• MDR Text Key: 297243005
• Report Number: 9610595-2022-00619
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170404047
• UDI-Public: 04953170404047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACECIDE-C
• Patient Outcome(s): Other