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

Model Number MAJ-2317

Device Problem Device Handling Problem (3265)

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

Event Type  malfunction  

Event Description

As reported for this event by the facility, the device (water filter) of automatic endoscopy reprocessor (aer) had not been replaced since the first use of the device approximately eight months before event was reported.There is no harm reported to any patient or persons.

Manufacturer Narrative

Full name of the facility is (b)(6) hospital.There are total 9 devices associated with this event (four automatic endoscopy reprocessors (aers), four water filters, and one unknown scope).These devices are captured in medwatches with patient identifiers as below: patient identifier model # serial # (b)(6), oer-5 (aer), (b)(4).(b)(6), oer-5 (aer), (b)(4).(b)(6), oer-6 (aer), (b)(4).(b)(6), oer-6 (aer), (b)(4).(b)(6), maj-2317 (water filter).(b)(6), maj-2317 (water filter).(b)(6), maj-2317(water filter).(b)(6), maj-2317 (water filter).(b)(6), cf-h290i representing the unknown scope.This medwatch is for the patient identifier (b)(6).The device has been returned but the device evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation and device evaluation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the dirty water had accumulated inside of the water filter, the water filter turned brown, and had a faint, strange smell.The likely root cause of the dirty water was poor reprocessing.It is possible that the water filter clogged because it was not replaced, and that water was not properly removed.As a result, it is possible sufficient reprocessing could not be performed and the concentration of acecide decreased.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿replace the water filter periodically, at least once in two months to prevent contamination of the rinse water.Replace the water filter at least once in two months.Otherwise, miscellaneous germs and stains in the water may contaminate the equipment and/or the endoscopes and prevent effective reprocessing.Disinfecting the water supply channel reduces the concentration of the disinfectant solution, making it unusable.Therefore, you are recommended to disinfect the water supply channel immediately before replacing the disinfectant solution.¿ 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15116753
• MDR Text Key: 304793770
• Report Number: 9610595-2022-00352
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• 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