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

Model Number	BF-UC180F
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was not returned to olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.
Event or Problem Description
A user facility reported to olympus that the distal end of the scope was missing a small piece.The problem, as reported to olympus, occurred and was first identified during reprocessing of the scope.There was no patient injury or harm, associated with the problem, reported to olympus.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the device evaluation and the legal manufacturer¿s investigation.The suspect device was returned to olympus and evaluated.Inspection of the device revealed damage to multiple components and the presence of multiple non-olympus parts.The device history record for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation determined the likely cause of the reported problem was an external force, added to the distal end.As stated in the instructions for use, as a preventive measure: "do not apply shock to the distal end of the insertion section, particularly the ultrasonic transducer and the objective lens surface at the distal end.Visual abnormalities may result.".

• 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
• MDR Report Key: 11624647
• Report Number: 8010047-2021-04667
• Device Sequence Number: 3280343
• Product Code: PSV
• UDI-Device Identifier: 04953170355608
• UDI-Public: 04953170355608
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 04/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1