MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC180F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to an olympus service center for evaluation.Inspection and testing confirmed the reported event.The biopsy port was loose due to physical stress.In addition, bending angle did not meet specification and the adhesive on the bending section cover had deterioration and separation of the thread-wound sections.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.
Event or Problem Description
The customer reported the metal part at the biopsy port on the scope had come off.Additional details were requested regarding the reported event.No additional information was provided.There was no harm or user injury reported due to the event.
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.The device met all specifications at the time of shipment.It has been nearly 5 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the damaged biopsy port could not be determined at this time.The following information is stated in the instructions for use which may have prevent the event: "do not apply excessive force to or bend the distal end of the endoscope.Instrument damage may occur." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Common Device Name: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• 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: 14118642
• Report Number: 8010047-2022-06428
• Device Sequence Number: 2276978
• Product Code: PSV
• UDI-Device Identifier: 04953170341823
• UDI-Public: 04953170341823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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-UC180F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2017
• 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