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

Model Number BF-XP190

Device Problem Mechanical Problem (1384)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.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, the bronchovideoscope had an issue with the 190xp scope when it was angulated.The customer is losing the image completely and the only way to get the image back is to release the angulating.The issue was found during procedure.There were no reports of patient harm.The customer was informed of the issue regarding the 190xp scopes and that market quality is still investigating the issue.

Event Description

The procedure being performed was a therapeutic bronchoscopy.The procedure was delayed by approximately 15 minutes while patient was under deep sedation.The intended procedure was completed with the use of a similar device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to the initial with information inadvertently left out (updated field a1, b3, d9, h3, and h4) and to provide additional information received through follow up (updated the device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was/was not confirmed.The complete evaluation results are as followed: image blacks out when angulated, channel leak, forceps passage tear inside channel wall, and insertion tube with multiple heavy bite/dent.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 image disappeared when angulated occurred by damage of the image sensor unit and/or its cable.However, the root cause could not be specified.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: 18381520
• MDR Text Key: 331486554
• Report Number: 9610595-2023-20192
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170434990
• UDI-Public: 04953170434990
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-XP190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2016
• 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
• Treatment: BF-XP160
• Patient Age: 3 YR
• Patient Sex: Male