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

Model Number	BF-3C160
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the reported event was not confirmed.However, it was found that the insertion tube had excessive buckles that could not pass the ring gauge, along with low angulation.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 bronchovideoscope did not display an image.It is unclear when the event occurred, but the customer noted that it was most likely during reprocessing.There was no procedure performed and no report of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.   new information added to the following field: h6.A review of the device history record and historical complaints analysis was conducted and no deviations that could have cause or contributed to the reported issues was identified.  based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The event can be [detected/prevented] by following the instructions for use which state:  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 field performance for 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: 18096953
• Report Number: 9610595-2023-16740
• Device Sequence Number: 6061279
• Product Code: EOQ
• UDI-Device Identifier: 04953170340031
• UDI-Public: 04953170340031
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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-3C160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 11/18/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2013
• 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