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

Model Number	BF-XP160F
Medical Device Problem Codes	Poor Quality Image (1408); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus employee reported on behalf of a customer, the evis exera bronchofibervideoscope displayed a whiteout image, and the insertion tube had a dent.The event occurred during preparation for use.The diagnostic bronchoscopy was completed using a replacement device without a delay.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of a whiteout image was not confirmed.The allegation of the connecting tube having a dent was confirmed.In addition, the coating was peeling off the insertion section.Due to damage on charge coupled device unit, the specified resolving power was not obtained.Image guide bundle had a stain.The adhesive on the bending section cover was detached.Due to a dent on channel tube, channel cleaning brush could not insert smoothly.Due to a dent on channel tube, forceps could not be inserted smoothly.The control unit had a scratch.Universal cord had a scratch.The image guide protector was damaged.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 (lm) final investigation.The b5 was corrected to include the reportable malfunction found by olympus personnel during the device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 5 years since the subject device was manufactured.Based on the results of the investigation, it is likely that "whiteout in image" and "peeling off coating of the insertion section" were both due to physical stress applied to the insertion section during user handling.The stress likely caused the charged coupled device (ccd) unit to become damaged affecting the image.However, a definitive root cause for the events could not be established.The "whiteout in image" event can be detected by handling the device in accordance with the following section of the instructions for use: "inspection of the endoscopic image." the "peeling off coating on insertion section" event can be detected by handling the device in accordance with the following section of the instructions for use: "inspection of the endoscope." in addition, both the events "whiteout in image" and "peeling off coating of insertion section" can be prevented by handling the device in accordance with the ifu which states: do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: coating on the insertion section was peeled.

• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• 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: 17187609
• Report Number: 9610595-2023-09210
• Device Sequence Number: 17594142
• Product Code: EOQ
• UDI-Device Identifier: 04953170340093
• UDI-Public: 04953170340093
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K033225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2023

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-XP160F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2018
• 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