MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES BRONCHOFIBERSCOPE

Model Number	BF-1T60
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the oes bronchofiberscope had air/water leaks.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the indication on the connecting tube had disappeared area.The report is being submitted due to indication disappearing on the connecting tube found during evaluation.
Additional Manufacturer Narrative
Additional details have been requested regarding the reported event.At this time, no additional information has been provided.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the complaint was confirmed and water tightness was lost due to a cut on the bending section cover.Also, evaluation found the bending section cover was cut and had slack, the bending section cover adhesive was detached, the connecting tube was wrinkled, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, the forceps could not be inserted smoothly due to a dent on the instrument tube, the image guide bundle was stained, and the connecting tube was dented.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the indication disappearing on the connecting tube as caused by stress of repeated use, external factors, or handling of the device.The event can be prevented by following the instructions for use which state: ¿¿chapter 3 preparation and inspection 3.2 inspection of the endoscope¿ as below.[inspection of the endoscope] 1.Inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts or other irregularities.2.Confirm that the instrument channel port does not rotate or turn by attempting to rotate or turn the instrument channel port in a counterclockwise direction as shown in figure 3.2.If the instrument channel port is able to be rotated or turned, do not use the endoscope and return it to olympus for repair.3.Visually inspect the rubber part around the instrument channel port.Figure 3.3 depicts the rubber part in a normal and abnormal condition.Lifting of the rubber part is abnormal.If the rubber part is lifted from the molding part as shown in figure 3.3, (abnormal condition) do not use the endoscope and return it to olympus for repair.4.Inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, scratching, holes, any protruding metal strain from inside the tube, bumps, sagging, transformation, bends, lifting of resin, peeling, adhesion of foreign body, dropout of parts or other irregularities.¿ olympus will continue to monitor field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• 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: 16322014
• Report Number: 9610595-2023-01968
• Device Sequence Number: 8813854
• Product Code: EOQ
• UDI-Device Identifier: 04953170339264
• UDI-Public: 04953170339264
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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-1T60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2014
• 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