MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS BRONCHOVIDEOSCOPE

Model Number BF-1T240

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, that the olympus endoscope reprocessor (oer) was used to improperly reprocess the bronchovideoscope.The water filter expired in 2021 and had not been replaced in more than two years, subsequently leading to the mismanagement of replacing the water filter in accordance with the instructions for use.There were no reports of patient harm, injury, or infection.Related patient identifiers: (b)(6).

Manufacturer Narrative

Additional information received from the customer confirmed that a third party company provided maintenance service to the hospital's equipment.The device was not returned to olympus for evaluation.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, it is likely that the user did not read instructions for use (ifu) thoroughly and used the water filter after replacement limit period expired by management error for replacement.However, a definitive root cause could not be determined.The suggested event is detectable/preventable by handling in accordance with the following instructions for use (ifu).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: EVIS BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• 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: 18540328
• MDR Text Key: 333216457
• Report Number: 9610595-2024-01188
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K963033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1T240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/1999
• 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