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

Model Number BF-1T180

Device Problem Device Reprocessing Problem (1091)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

It was reported to olympus, that the evis exera ii bronchovideoscope outer skin was torn apart from the scope.The issue occurred when the water cap was left on the scope during reprocessing through the v-pro.There were no reports of patient harm associated with the event.

Manufacturer Narrative

The device was returned for evaluation and the customers allegation was confirmed.It was noted that leak test was not completed as the leak could not be sealed.It was also noted that the bending section rubber was blown out which affected the insulation.The distal end plastic cover had a dent and the bending section rubber glue was peeling.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, a definitive root cause of the reported water cap being left on during reprocessing issue could not be determined, as the customer could not provide additional detailed information regarding the "v-pro" sterilizer used, however, the result of the issue was damage to the scope and improper/insufficient reprocessing.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 16919769
• MDR Text Key: 315101646
• Report Number: 9610595-2023-07401
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170339325
• UDI-Public: 04953170339325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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: BF-1T180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2013
• 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