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

Model Number BF-P190

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

It was reported that during reprocessing the department did not have a suction source to properly reprocess the scopes within their department.There were no reports of patient involvement.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The customer was advised to obtain a suction source to properly reprocess their scopes.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 supplemental report is being submitted to provide the results of the legal correction to g3 of the initial medwatch.The aware date should be 30 novemeber 2023 as that was the date in service was requested.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over two (2) years since the subject device was manufactured.Based on the results of the investigation, it is likely the user's understanding on device handling and reprocessing steps differed from olympus recommendations.An olympus endoscopy support specialist (ess) was dispatched on 02 february 2024, to observe the user facility¿s reprocessing practices from start to finish and provide a reprocessing in-service training, if necessary, to correct and address any reprocessing deviations.During the in-service the ess covered the guidelines on reprocessing the olympus scope per the on-track form and reprocessing manual.The staff also performed a return demonstration to show they understood the process.The customer also understood that the olympus reprocessing manuals are the validated source of instructions.The preventative measures for the reported issue are located in the following chapter of the instructions for use: reprocessing manual "chapter 5 reprocessing the endoscope".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 18668918
• MDR Text Key: 336190904
• Report Number: 9610595-2024-02750
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342110
• UDI-Public: 04953170342110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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-P190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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