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

Model Number	BF-XT160
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the bronchovideoscope only displayed stripes on the image.It is unknown when the issue occurred.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Device was returned and the customer's allegation was confirmed.The device evaluation found the defect was caused by wear and tear of the charged coupled device unit.Based on the results of the investigation, olympus confirmed the biopsy channel was leaking 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.A device history review revealed no issues that could have caused or contributed to the reported issue.Labeling: this issue is addressed in the instructions for use (ifu): important information ¿ please read before use 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.Precaution for disappeared or frozen endoscopic image; caution turn the video system center off before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope.Turn the switch on or off only when the videoscope cable is connected to both the video system center and electrical connector on the endoscope.Failure to do so can result in equipment damage, including destruction of the ccd.Do not touch the electrical contacts inside the electrical connector.Ccd damage may result.3.6 inspection of the endoscopic system: inspection of the endoscopic image: 4.While observing the palm of your hand, confirm that the wli and nbi endoscopic image is free from noise, blur, fog, or other irregularities.5.Angulate the bending section and confirm that the endoscopic image is free from momentary disappearing or 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 the field performance of this device.

• Brand Name: EVIS EXERA 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: 19272276
• Report Number: 9610595-2024-09384
• Device Sequence Number: 17884356
• Product Code: EOQ
• UDI-Device Identifier: 04953170340147
• UDI-Public: 04953170340147
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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-XT160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2011
• 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