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

Model Number OER-4

Device Problems Device Reprocessing Problem (1091); Failure to Disinfect (1175)

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

Event Date 11/06/2022

Event Type  malfunction  

Manufacturer Narrative

An on-site service visit to the facility was performed.During the visit, the olympus representative provided guidance on proper uses of the device, including filter replacement.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported that the customer had contacted the olympus call center and stated that the endoscope reprocessor was not working properly and was displaying an error code e01 message.During the troubleshooting of the device, the technician guided the customer through the air bleeding work and confirmed that the water filter had not been replaced since september 2020.Although the number of examinations was not large, it has not been confirmed whether scopes that had been cleaned and disinfected in this state had been used on any patients.This report is to capture the reportable malfunction of poor reprocessing due to inadequate filter handling.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.Section g2 was corrected to accurately indicate the report source as a healthcare professional.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, it is possible that there was a user mistake in managing the replacement of the water filter and that error occurred because the specified time had passed since the water supply started.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿7.2 replacing the water filter (maj-2318) replace the water filter periodically, at least once in one months to prevent contamination of the rinse water.Warning: always be sure to attach the water filter.Otherwise, miscellaneous germs and stains in the water may contaminate the equipment and/or the endoscopes and prevent effective reprocessing.¿ olympus will continue to monitor field performance for 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15914888
• MDR Text Key: 308184838
• Report Number: 9610595-2022-04874
• 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,Followup
• Report Date: 03/24/2023

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: 11/06/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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