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

Model Number OER-4

Device Problem Device Reprocessing Problem (1091)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that the endoscope reprocessor displayed an e73-water supply error during reprocessing.The customer waited until the function started, but then an e01-long water supply time error occurred.There was no report of patient harm.In speaking with an olympus service representative (rep), the customer noted that the water filter was replaced in (b)(6) of 2022.They also added that the event was possibly due to long-term non-exchange.This report is linked to the following patient identifiers (b)(6).

Manufacturer Narrative

The device was not returned to olympus, and it is not expected to be returned for evaluation of the reported issue.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over four years since the subject device was manufactured.Based on the results of the investigation, the reported events was most likely caused by the user's unfulfillment of thoroughly reading the instruction manual and the user's mismanagement of replacing the water may have caused the subject event.However, the root cause of the events could not be determined.The subject event can be detected and prevented by implementation in accordance with below ifu: instructions, operation manual chapter 7 ¿routine maintenance¿ section 7.2 ¿replacing the water filter (maj-2318)¿ replace the water filter periodically, at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever the error code [e01] indicating water supply insufficiency is displayed.Olympus will continue to monitor the field performance of this device.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18302668
• MDR Text Key: 330334205
• Report Number: 9610595-2023-19235
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/11/2023

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-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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