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

Model Number OER-MINI

Device Problem Device Reprocessing Problem (1091)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  Injury  

Event Description

A customer reported to olympus that the unit (oer mini endoscope reprocessor) failed the test strip for the disinfectant.The customer initially asked for instructions on how to change the disinfectant and was provided the instruction manual for the device.At that time, the customer reported that there was an infection.No other additional information was reported.The customer was contacted multiple times, but no further information was received.

Event Description

It was additionally reported by the customer that the issue was resolved the same day it was reported.The facility ran another cycle and the test strips passed.No patients were affected.It was further clarified that no scopes were processed until the matter was fixed, and there were no infections/concern for infection.

• 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: 17896477
• MDR Text Key: 325245558
• Report Number: 2429304-2023-00321
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170331619
• UDI-Public: 04953170331619
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2023,11/15/2023

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-MINI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other