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

Model Number	BF-1T60
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
A user facility submitted a repair request to the olympus service center, for the oes bronchofiberscope for leaking at the insertion part tube.Upon inspection and testing of the customer returned device, the coating of the insertion guide serpentine tube was found peeled off.(1 to 2 mm or more).This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no patient involvement, or user injury associated with this event.
Additional Manufacturer Narrative
The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, water tightness not maintained due to holes in the insertion part serpentine tube, bending angle is insufficient due to the elongation of the angle wire, curved tube closer to the blade, insertion part serpentine crushed, scratches on the insertion part serpentine, coating of the insertion part serpentine tube peeled off, curved rubber adhesive missing, universal code crushed, scratches on the universal code, scratches on the operation part, scratches on the eyepiece, scratches on grip, angle lever scratched, scratches found on up/down plate, and light guide connector scratched.The faulty parts were replaced, and the device was returned to the user facility.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 final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.However, it was presumed that the causes were stress during operation, external factors or handling.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15021034
• Report Number: 9610595-2022-00009
• Device Sequence Number: 6857334
• Product Code: EOQ
• UDI-Device Identifier: 04953170339264
• UDI-Public: 04953170339264
• 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): 09/16/2022

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-1T60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2016
• 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