MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES BRONCHOFIBERSCOPE

Model Number	BF-1T60
Medical Device Problem Codes	Fluid/Blood Leak (1250); 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 returned the olympus, the oes broncho fiber videoscope to the service center due to a leakage in the bending section cover.Upon evaluation of the returned device, it was observed the bending manipulation and insertion tube was defective with peeling of the coating from the insertion section.This report is being submitted for the event found during evaluation.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The evaluation concluded, the bending manipulation and insertion tube was defective with peeling of the coating from the insertion section, wrinkles in the insertion part, watertightness is not maintained due to holes in the curved rubber, the play of the angle lever is out of the normal state due to the extension of the angle wire and the curved tube is crushed due to an external factor.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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 15 years since the subject device was manufactured.Based on the results of the investigation, and although we could not specify the root cause of the suggested event, it is likely the defect was caused by repeated excessive wiping of the outer surface of the insertion section, or chemical deterioration by chemical solutions.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 16-jan-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13536858
• Report Number: 8010047-2022-02986
• Device Sequence Number: 17159673
• 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,Followup
• Report Date (Section B): 12/12/2022

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: 01/16/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/25/2022; 11/08/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/21/2022; 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2005
• 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