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

Model Number OER-PRO

Device Problem Leak/Splash (1354)

Patient Problems Dyspnea (1816); Headache (1880); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

H6 appropriate term: shortness of breath and runny nose.This device has not been returned for evaluation.This report has been submitted by the importer under this mdr report number 2429304-2023-00211.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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 staff member was brought to an urgent care facility.

Manufacturer Narrative

This report is being supplemented to provide additional information from customer.This report has been submitted by the importer under this mdr report number 2429304 -2023 - 00211-1.

Event Description

Olympus further received information and 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.

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 over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the acecide was leaking at the bottle¿s opening, which resulted in the user¿s exposure and adverse event (shortness of breath, dizziness, and headache).However, the root cause could not be determined.This supplemental report includes new information received from the customer.B5 has been updated accordingly.Also, additional information has been added to h4.A correction has been made to h6 (health effect ¿ clinical code) to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received from the customer: it was confirmed that the staff member wore appropriate personal protective equipment (ppe), such as an eyewear, a face mask, a moisture-resistant clothing and chemical-resistant gloves when he/she used the acecide bottle.In addition, the staff member used the acecide bottle in a place that had good ventilation.

• 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17262933
• MDR Text Key: 318454212
• Report Number: 9610595-2023-09734
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

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?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/17/2023; 08/07/2023
• Supplement Dates FDA Received: 08/01/2023; 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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): Required Intervention; Other