MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. WATER FILTER

Model Number MAJ-824

Device Problem Device Reprocessing Problem (1091)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that the water filter was suspected of poor reprocessing due to inadequate water filter handling or inadequate water supply piping disinfection after water filter replacement was used for the patient.The issue occurred during an unknown diagnostic procedure.The customer did not report if the procedure was completed.There were no reports of patient harm.Related complaint identifier: (b)(6).

Manufacturer Narrative

No device was returned to olympus for evaluation.However, as part of the investigation into this report, an olympus endoscopy support specialist (ess) has been dispatched on-site to assess the reprocessing practices and investigate the error code 83 at the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the poor reprocessing was due to inadequate water filter handling/inadequate water supply piping disinfection after water filter replacement was used for the patient.The user did not read instructions thoroughly, used the water filter after replacement limit period expired by management error for replacement.The event can be detected/prevented by following the instructions for use which state: ¿oer-aw operation manual.Chapter 7 routine maintenance.7.2 replacing the water filter (maj-824).Replace the water filter at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever an error code indicating water supply insufficiency [e01] is displayed.The water filter should be replaced by following the flow shown below.¿ olympus will continue to monitor field performance for this device.

• Brand Name: WATER FILTER
• Type of Device: WATER FILTER
• 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: 18712285
• MDR Text Key: 336537501
• Report Number: 9610595-2024-03261
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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: MAJ-824
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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