MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES BRONCHOFIBERSCOPE

Model Number BF-P10

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

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.

Event Description

The customer reported to olympus, that the olympus endoscope reprocessor (oer) was used to improperly reprocess the bronchofiberscope.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

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, as the device was not returned, the root cause of the reported event is unable to be determined.However, it is presumable the reported event is due to the user did not read instructions for use (ifu) thoroughly, used the water filter after replacement limit period expired by management error for replacement.The event can be detected and prevented by following the ifu sections: 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: OES BRONCHOFIBERSCOPE
• Type of Device: BRONCHOFIBERSCOPE
• 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: 18543886
• MDR Text Key: 333255466
• Report Number: 9610595-2024-01224
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K962380
• 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: 03/07/2024

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: BF-P10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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