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

Model Number	BF-3C40
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported olympus that the oes bronchofiberscope had leak.There were no reports of patient harm.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: peeling of the coating in the insertion part of the connecting tube (1mm squared or more).
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's complaint was confirmed; due to a pinhole in the connecting tube, water tightness was lost.In addition to the peeling of the coating in the insertion part of the connecting tube (1mm squared or more), the evaluation findings were as follows: the adhesive on the bending section cover had a chip, the connecting tube had a wrinkle, due to wear of the angle wire, bending angle in the "up" direction did not meet standard value, the adhesive around the objective lens was peeled, the adhesive around the light guide lens was peeled, the control unit was sticky due to water leakage, the scope cover had discoloration, the control unit had discoloration, the image guide bundle had a stain, the connecting tube had a dent, the "upward/downward" plate had discoloration, the grip had discoloration, the universal cord had a dent, and the eyepiece was deformed.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.Based on the results of the investigation, it is likely that physical stress was applied to the insertion section during user handling and caused the coating to peel.However, a conclusive root cause could not be determined.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: 3.2 preparation and inspection of the endoscope 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17607404
• Report Number: 9610595-2023-12106
• Device Sequence Number: 6263313
• Product Code: EOQ
• UDI-Device Identifier: 04953170339219
• UDI-Public: 04953170339219
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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-3C40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2009
• 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