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

Model Number BF-P190

Device Problems No Display/Image (1183); Defective Component (2292)

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

Event Type  malfunction  

Event Description

The bronchovideoscope was returned as part of the asset return process.During routine inspection of the device by olympus, no image was displayed due to a defective plug unit.There was no procedural or patient involvement associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned to olympus as part of the asset return process.Upon evaluation, no image was displayed due to a defective plug unit.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6.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 could not be determined.However, it is likely that no image occured due the plug unit that may have been damaged by electrical factor.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: 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¿.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: 18764598
• MDR Text Key: 336059583
• Report Number: 9610595-2024-03801
• Device Sequence Number: 1
• Product Code: EOQ
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-P190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2021
• 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