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

Model Number BF-1TQ290

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

The customer reported that his staff had inadvertently incorrectly reprocessed his olympus evis lucera elite bronchovideoscope.According to the initial reporter, the scope had been washed but the filters on his olympus endoscope reprocessors had not been replaced since 21may21.The customer confirmed that he has 2 olympus reprocessors on site.Consequently, he could not confirm which scopes were cleaned in which unit.The total number of possible events is unknown.However, the customer did confirm a total of 15 devices were involved ¿ 2 processors and 13 scopes.There was no patient harm reported as a result of the above event.This report is capturing event 4 of 15.For the related events, please see reports with the following patient identifiers: (b)(6).

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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, the root cause of the incorrectly reprocessed device occurred since the user failed to thoroughly understand the maintenance method of the subject device.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 16467155
• MDR Text Key: 310862528
• Report Number: 9610595-2023-03566
• Device Sequence Number: 1
• Product Code: EOQ
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TQ290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• 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