MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-ELITE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Aspiration Pneumonitis (4455)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.A field service engineer (fse) is being dispatched to the facility to evaluate the device onsite.This evaluation has not yet taken place.The investigation is ongoing.The definitive cause of the users experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238-2021-00340.

Event Description

It is reported an oer-elite displayed an unspecified error code, prompting the end user to open the device and pull out the acecide.At this time, the acecide leaked, causing fumes leading to breathing issues in this end user.It is unknown if there was an actual issue with the oer-elite or if it was user error in loading the acecide and not properly securing the door after loading.The end user was seen in the emergency for evaluation.The person was diagnosed with pneumonitis, given two breathing treatments in the emergency room, and was discharged from the emergency room with a steroid inhaler.The person's current condition is well and back to work with no further issues.

Manufacturer Narrative

This report is being submitted to report investigation findings.New information is reported in: the device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: chapter 8.2 replacing the disinfectant solution.Before handling the disinfectant solution, read the cautions carefully and use as instructed.It is especially important to know what to do if the disinfectant solution comes in contact with your skin and eyes.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.Do not touch inside the caps of cassette bottles.Do not push or apply strong pressure to the bottle.Otherwise, disinfectant solution may leak from the bottle.An olympus field safety engineer went onsite to evaluate the suspect device and provide education to the staff.No device issue was found and there was no error log retrieved.Conclusion: no device issue was identified.Based on investigation findings, it is presumed that ¿e51: fluid leakage inside the oer-elite¿ occurred due to acecide leakage based.The likely cause of e51 error message, is that the acecide bottle was not properly set when the user mixed acecide or the user set the bottle with defect: such as hole inside the acecide bottle cap.It is likely that the user pulled up on the acecide bottle because e51 occurred, causing the reported event.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11898685
• MDR Text Key: 261920041
• Report Number: 8010047-2021-06828
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2020
• 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
• Patient Outcome(s): Required Intervention; Other