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

Model Number	BF-P180
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the reported event was confirmed; a leak was found on the bending section cover, and there was a dent on the insertion tube.Other evaluation findings are as follows: there was a hole on the bending section cover; and there was no image on the monitor after the electrical connector.Attempts to retrieve additional information from the customer are in progress.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported that the patient bit down on the bronchovideoscope in multiple places during the procedure.There was no report of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to e2, e3, h4.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, the root cause of the image issue was physical stress was applied to the insertion section while the user was handling the subject device.As a result, the image sensor unit had abnormality, and the image was not displayed.The event can be detected/prevented by following the instructions for use which state: ¿important information ¿ please read before use: warnings and cautions: caution: turn the video system center on only when the videoscope cable is connected to both the video system center and the electrical connector on the endoscope.In particular, confirm that the video system center is off before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope.Failure to do so can result in equipment damage, including destruction of the ccd.Precaution for disappeared or frozen endoscopic image: warning: follow the precautions given below when handling the instrument.Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.3.6 inspection of the endoscopic system: inspection of the endoscopic image: 3.While observing the palm of your hand, confirm that the wli and nbi endoscopic image is free from noise, blur, fog, or other irregularities.4.Angulate the endoscope and confirm that the wli and nbi endoscopic image does not momentarily disappear or display any other irregularities.Chapter 5 troubleshooting: if the endoscope is visibly damaged, does not function as expected, or is found to have irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope.Contact olympus.Some problems that appear to be malfunctions may be correctable by referring to section 5.1, ¿troubleshooting guide¿.If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to olympus for repair.Olympus does not repair accessory parts.If an accessory part becomes damaged, contact olympus to purchase a replacement.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: 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: 17883040
• Report Number: 9610595-2023-14705
• Device Sequence Number: 17999603
• Product Code: EOQ
• UDI-Device Identifier: 04953170308192
• UDI-Public: 04953170308192
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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
• Operator of Device: Health Professional
• Device Model Number: BF-P180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown