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

Model Number BF-1T180

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

The customer will not provide any information on the patient.Due diligence was performed, and additional information was received from the customer for this event.The device is returned, and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the as received condition of the device, it was observed that the distal end plastic cover, objective lens, light guide lens, and distal end rubber coating (a-rubber) were missing.The internal elements of the device were visible.Due to the missing elements, leak test and electrical continuity tests could not be performed.The device yielded no image.There was loss of scope id data.The device also had low angulation.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, at the beginning of a diagnostic bronchoscopy procedure, the device broke upon insertion into endotracheal tube (et tube).The physician withdrew the scope and removed the distal end cover with his hands and threw the distal end cover in the trashcan.No parts remained in the et tube.The procedure was completed with another similar device, so rescheduling of the procedure was not required.There was approximately 15 minutes delay to the completion of the procedure while another device was being obtained.The patient time under anesthesia was increased by the additional minutes of the delay.There is no harm or adverse impact to the patient.The device was inspected prior to use with no anomaly noted.The device was not dropped nor came in contact with a hard surface.

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.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, the reported event likely occurred due to the following factors: lubricant was insufficiently applied to the insertion section or there was not enough gap between the insertion section and the et tube.Therefore, when inserted/withdrew the device into/from the et tube, the insertion section got stuck in the tube.The user forcibly withdrew the stuck device from the tube.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: 15841917
• MDR Text Key: 307909657
• Report Number: 9610595-2022-04409
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-3285-2018
• Patient Sequence Number: 1
• Treatment: OLYMPUS EVIS EXERA III LIGHT SOURCE SN (B)(4); OLYMPUS EVIS EXERCA III PROCESSOR SN (B)(4)