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

Model Number	BF-3C40
Medical Device Problem Codes	Degraded (1153); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation of defects of the bending section and insertion tube were confirmed.The device evaluation found that the connecting tube had coating that was peeling.Additional evaluation findings were as follows: due to a dent on bending tube, bending angle in up direction exceeds the standard value, due to a dent on the channel-tube, the forceps and the channel cleaning brush could not be inserted smoothly, the adhesive around the objective lens was peeled, the eyepiece was deformed, the image guide bundle was stained, the bending section cover was elongated, the connecting tube had a dent , a wrinkle and was discolored.A review of the device history record found no deviations that could have caused or contributed to the coating on the connecting tube peeling, the device was shipped in accordance with specifications.The device met all specifications at the time of shipment.Based on the results of the investigation, the cause of the coating on the connecting tube peeling could not be determined.Although the root cause cannot be conclusively identified it was presumed that the defect was caused by stress of repeated use, external factors, or handling.The instruction manual operation manual ¿chapter 3 preparation and inspection, 3.2 preparation and inspection of the endoscope¿ describes the following warning.4.Visually 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, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.6.Carefully run your fingertips over the entire length of the insertion tube.Inspect for any protruding objects or other irregularities (see figure 3.4).7.Visually inspect the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.Feedback to the customer from the service business center (sbc) recommended to the user to read the ifu instruction manual again to conduct the handling in line with the ifu, for prevention of recurrence.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus, that there were defects of the bending section and insertion tube on the oes bronchofiberscope.During inspection and testing of the returned device it was found that the connecting tube had coating that was peeling.There was no report of delay or harm to a patient or user.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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: 17279346
• Report Number: 9610595-2023-09843
• Device Sequence Number: 19703082
• 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): 07/07/2023

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: 06/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2002
• 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