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

Model Number BF-XP190

Device Problem Poor Quality Image (1408)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

The customer reported the evis exera iii bronchovideoscope had a scope connection error.The customer did not provide an error code.The issue occurred when preparing the scope for use.The procedure was completed with another scope.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the image was intermittent/flickering.The report is being submitted due to the image problem found during evaluation.

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found there was no data transmission, the bending section cover and instrument channel were leaking, the bending section cover adhesive was peeled and had a hole, and the insertion tube was dented.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to biopsy channel leakage while the user was handling the device, and water invaded the device.Due to the water invasion, abnormality of electronic parts occurred which led to the malfunction.It is suggested that the user facility review the method of handling for the device according to the instructions for use (ifu).The instructions for use (ifu) state the following regarding the suggested phenomenon: "important information ¿ please read before use.¦precautions: caution.Turn the video system center on only when the endoscope connector is connected to the light source.In particular, confirm that the video system center is off before connecting or disconnecting the endoscope connector.Failure to do so can result in equipment damage, including destruction of the image sensor.¦precautions for disappeared or frozen endoscopic image: warning follow the precautions given below.Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.3.8 inspection of the endoscopic system.¦inspection of the endoscopic image.Confirm that the wli and nbi [white light imaging and narrow band imaging] endoscopic images are normal.5.1 troubleshooting.If any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2,¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described section 5.3, ¿withdrawal of the endoscope with an irregularity¿." 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: 17487437
• MDR Text Key: 321643060
• Report Number: 9610595-2023-11391
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342134
• UDI-Public: 04953170342134
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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