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
Additional Manufacturer Narrative
E1) establishment name: (b)(6).The device was returned to olympus for evaluation.And the customer's allegation was confirmed.The bending section could not be bent in the up direction at all; due to a cut on the angle wire.In addition to the peeling coat of the image guide serpentine, other evaluation findings are as follows: the bending section cover had a slack, the bending section cover adhesive had a chip, the connecting tube had a wrinkle, the forceps could not be inserted smoothly; due to damage on the channel tube.The light guide lens had discoloration, the bending tube had a dent, there was buckling on the connecting tube, the image guide had several significant breakage, the light guide connector was dirty, and the universal cord had a dent.Lastly, there were scratches on the following parts: the scope cover, the light guide connector, the universal cord, the angulation lever, the up/down angulation lever plate, the grip, the control unit, the diopter ring, the eyepiece, and the forceps channel port.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication, that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed, and no issues were found related to the reported event.The device was not repaired within the past year.Although it was determined, that the defect was likely caused by stress of repeated use, external factors, or handling, a definitive root cause of the peeled coating could not be identified.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus, that the bending operation of the oes bronchofiberscope was disabled.There was no report of patient harm.The device was returned, evaluated.And the it was found, that the coating of the image guide serpentine was peeling off (1mm2 or more).This mdr is being submitted to capture the reportable malfunction found during the device 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: 17209517
• Report Number: 9610595-2023-09344
• Device Sequence Number: 12410181
• 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): 06/27/2023

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: 05/28/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2009
• 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