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 to olympus, the bronchofiberscope had scratches on the universal cord, meandering of the insertion part, discoloration of the connector and operation parts.The device was returned for evaluation.During testing and inspection of the device, the following reportable malfunction was found: coat of the image guide pipe was peeling off (1x1mm2 or more).There were no reports of patient harm or impact associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned for evaluation.During the device evaluation, it was determined that the coat of the image guide pipe was peeling off (1x1mm2 or more).Additionally, the evaluation revealed the following findings: angulation lever, bending section cover, and light guide lens had discoloration; universal cord had a cut; light guide connector, grip, eyepiece, and connecting tube had discoloration; due to a crack on control unit, water tightness was lost; connecting tube had a dent; due to damage on image guide bundle, the image had a stain; image guide bundle had significant breakages; suction cover, control unit, up/down angulation lever plate, grip, diopter ring, eyepiece, and angulation lever had a scratch; universal cord had buckling; due to damage on channel tube, channel cleaning brush and forceps could not be inserted smoothly; due to damage, angulation lever did not move smoothly; due to wear of angle wire, bending angle in up direction did not meet the standard value; connecting tube had a wrinkle; due to a cut on universal cord, water tightness was lost; and adhesive around objective lens and forceps channel port had corrosion.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 were identified.Based on the results of the investigation, the root cause of the peeling connecting tube coating 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 which state: ¿3.2 preparation and inspection of the endoscope.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18311714
• Report Number: 9610595-2023-19356
• Device Sequence Number: 6151951
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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: 11/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/1999
• 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