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

Model Number OER-PRO

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2022

Event Type  Injury  

Event Description

The customer reports an oer-pro endoscope reprocessor displayed e16 error then e18 error.There was also an acecide leak which affected several staff members (unknown how many or how they were affected).It is not known if any of the staff members required intervention.The current condition of the staff members is not known.Additional details regarding the staff members at the reported event have been requested.At this time, no further information has been provided.The mfr medwatch report associated with this event was submitted on time under manufacturer report # 8010047-2022-04451.Upon review olympus is submitting the corresponding importer medwatch report.

• 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: 17035025
• MDR Text Key: 316318494
• Report Number: 2429304-2023-00169
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/16/2022,05/31/2023

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: 02/16/2022
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other