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
Additional Manufacturer Narrative
Establishment name: (b)(6) this report is being sent to provide information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint "distal end leaky¿ was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be conclusively identified.However, based on the phenomenon and information obtained, we presume that the defect was caused by stress of repeated use, external factors, or handling.The event can be prevented by following the instructions for use which state: 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.In addition, the following non-reportable malfunctions were found during the device evaluation: broken fiber, image guide bundle has significant breakages, due to a pinhole on bending section, water tightness is lost, adhesive on bending section has a chip, due to wear of angle wire, bending angle in up direction does not meet specifications, due to damage on channel-tube, forceps and channel cleaning brush cannot be inserted smoothly, objective lens has discoloration, bending and connecting tube have a dent, and several scratches found throughout the device.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the oes bronchofiberscope had a sunspot in the field of view.During inspection and evaluation, the coat on the image guide snake pipe is peeling off.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during incoming inspection and 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: 17394957
• Report Number: 9610595-2023-10601
• Device Sequence Number: 5921840
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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: 06/28/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2009
• 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