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

Model Number OER-PRO

Device Problem Leak/Splash (1354)

Patient Problems Headache (1880); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/09/2023

Event Type  Injury  

Event Description

The customer reported to olympus that when replacing acecide cartridge at preparation for use, a tech nurse opened a leaky cartridge and was exposed to fumes causing shortness of breath, dizziness and headache and runny nose.The user was brought to the customer reported to olympus that when replacing acecide cartridge at preparation for use, a tech nurse opened a leaky cartridge and was exposed to fumes causing shortness of breath, dizziness and headache and runny nose.The staff member went to an urgent care facility.

Event Description

Olympus further received information that the staff experienced severe shortness of breath that required emergency department visit and was treated with inhaler multiple times and steroids.The symptoms were resolved and staff's current condition is good.No other information was provided.

• 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
• MDR Report Key: 17263979
• MDR Text Key: 318565575
• Report Number: 2429304-2023-00211
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/09/2023,08/01/2023

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-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACECIDE-C.
• Patient Outcome(s): Required Intervention; Other