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

Model Number BF-XP190

Device Problems Crack (1135); No Display/Image (1183); Peeled/Delaminated (1454)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the bronchovideoscope had no image ¿ blank screen.The issue is unknown.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus and the evaluation findings were a-rubber (bending section cover) was pierced.The a-rubber (bending section cover) glue was peeled.The forceps passage was restricted, buckling and deformation of the channel.After angulation, the up image was off.The insertion tube was dented.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned, and an evaluation was completed.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, it is likely that the charged couple device (ccd) cable was pressed and about to break, which caused no image during angulation to occur.However, a definitive root cause could not be determined.In addition, based on the results of the investigation, and because the phenomenon (blank screen) was not duplicated during device evaluation, the root cause of the phenomenon could not be identified.The following information is stated in the instructions for use (ifu): ¿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.

Event Description

The customer reported the issue was found during pre-test for an unknown diagnostic procedure.There was no delay, and the procedure was completed with the device.There was no reported patient harm or impact due to this event.

• 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: 18535054
• MDR Text Key: 333133116
• Report Number: 9610595-2024-01123
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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