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

Model Number BF-XP190

Device Problem Device Reprocessing Problem (1091)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.The image was found intermittently when the unit was in the ¿up¿ position.Additionally, the biopsy channel had a leak present, and the insertion tube as well as the adhesive were both compromised.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer reported that his olympus evis exera iii bronchovideoscope was producing an intermittent image whenever the scope was manipulated.According to the initial reporter, this event took place during reprocessing and had no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.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 were identified.Based on the results of the investigation, a definitive root cause of the reported image loss upon angulation issue could not be determined, however, the issue was likely due to physical stress applied to the insertion site during user handling/mishandling, resulting in damage to the image sensor the image sensor unit.The event can be detected/prevented by following the instructions for use (ifu) which states: 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 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: 17895285
• MDR Text Key: 325828277
• Report Number: 9610595-2023-14781
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• 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