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

Model Number OER-6

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the olympus endoscope reprocessor had the first e99 outbreak and discovered that there was a mistake in the acecide check method.Even if the checker paper shows white (no concentration) 7 seconds after liquid removal, if it turns black over time, it has been incorrectly determined that there is no problem with the concentration.The issue occurred during reprocessing.There were no reports of patient harm or infections.

Event Description

The costumer reported that the event was completed with the same equipment.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and 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 one (1) year since the subject device was manufactured.The device was to olympus for inspection, and the customer's complaint was not confirmed.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the "incorrectly judge of judgement paper" malfunction would likely be related to the facility staff that used the aseside checker incorrectly, judging the concentration to be valid even when the reaction zone of the aseside checker turned black over a long period of time.The event can be prevented by following the instructions for use which state: follow the procedure described in the ¿instruction manual¿ of "how to use the acceside checker " to determine the concentration.Note 3: the reaction progresses over time and coloration proceeds.Please judge within the specified time.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS 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: 18699755
• MDR Text Key: 336509174
• Report Number: 9610595-2024-03096
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2023
• 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