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

Model Number	BF-XP60
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 to olympus that there was a leakage issue while using the oes bronchofiberscope.There was no patient harm associated with the event.The device was returned and evaluated, and the coating of the ig serpentine was peeling off.(1mm2 or more).This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed by reproducing the user identified defect.The additional evaluation findings are as follows: the coating of the image guide serpentine was peeling off (1mm2 or more), the adhesive on the bending section cover had a chip; due to a dent on the bending tube, the play of the right/left knob was out of standard value; connecting tube had a dent, and the universal cord had a wrinkle.The following device components were found to be scratched: eyepiece, control unit, scope cover, grip, angulation lever, up/down plate, universal cord, and the light guide connector.The following is 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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the suggested event could not be determined.However, it is presumed that the event was caused by stress of repeated use, external factors, or handling of the device.The event can be detected/prevented by following the instructions for use (¿chapter 3 preparation and inspection 3.2 inspection of the endoscope¿ )which state: 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, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.6.Holding the insertion tube gently with a hard, carefully run your fingertips over the entire length of the insertion tube in both directions.Inspect for any protruding objects or other irregularities.Also confirm that the insertion tube is not abnormally stiff.Olympus will continue to monitor field performance for this device.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• 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: 17279714
• Report Number: 9610595-2023-09849
• Device Sequence Number: 5183857
• Product Code: EOQ
• UDI-Device Identifier: 04953170339240
• UDI-Public: 04953170339240
• 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-XP60
• 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: 06/13/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2012
• 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