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

Model Number	BF-P180
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus the evis exera ii bronchovideoscope, image problem, no contact taking pictures.The issue occurred during reprocessing.The procedure was unknown.There were no reports of patient or user harm associated with this event.Inspection and testing of the returned device found that there was no image.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during the evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found the following: distal end plastic cover had a chip; intermittent and flickering image; switch#1, #2, #3 and #4 were not working; and insertion tube had a bite/dent and it was smashed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 was identified.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to physical stress that was applied to the insertion section during user handling.It caused an abnormality in the image sensor unit and the suggested event occurred.It is suggested that the user facility review the method of handling for the device according to the instructions for use (ifu).The instructions for use (ifu) state the following regarding the suggested phenomenon: "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 [white light imaging and narrow band imaging] 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: 17855252
• Report Number: 9610595-2023-14433
• Device Sequence Number: 12433145
• Product Code: EOQ
• UDI-Device Identifier: 04953170308192
• UDI-Public: 04953170308192
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 09/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2009
• 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