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

Model Number	BF-1T60
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated.Additional findings include; due to a cut on bending section cover, water tightness was lost.Indication on connecting tube had a disappeared area.Plastic distal end cover had foreign objects and was deformed.Due to deformation of distal end, the specified resolving power was not obtained.Light guide bundle had a stain.Color ring had a crack.Control unit was damaged.Because channel tube was crushed, forceps could not be inserted.Due to wear of angle wire, bending angle in up direction did not meet the standard value.Connecting tube had a wrinkle.Adhesive on bending section cover had a chip.Bending section cover had a cut.Connecting tube had a dent.The investigation is ongoing, this report will be supplemented when new and relevant information becomes available.
Event or Problem Description
It was observed that during the device evaluation that the coating was peeled from the soft tube and there was foreign matter on the tip cover of the bronchofiberscope.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final 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 ten (10) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the coating on insertion tube peeled off was caused by stress of repeated use, external factors, or handling.Upon further follow up with the customer, it was determined that the foreign material adhered to the device is not reportable.The device was returned for evaluation without reprocessing and as a result would have foreign material.The event can be detected by following the instructions for use which state: ¿chapter 3 preparation and inspection, 3.2 inspection of the endoscope¿ describes the methods for inspection on the suggested event.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: 18710692
• Report Number: 9610595-2024-03234
• Device Sequence Number: 7084327
• Product Code: EOQ
• UDI-Device Identifier: 04953170308161
• UDI-Public: 04953170308161
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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: Other
• Device Model Number: BF-1T60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2013
• 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