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

Model Number	BF-UC180F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and a device evaluation completed for it.Manufacture date is not known.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the device probe tip was broken.The device passed dunk test and cosmos passed no fluid anywhere in the scope.The light guide tube had surface scratches, the distal end rubber coating had a crack, and insertion tube had scratches.Wear and tear was observed for the device.Evaluation is ongoing.Supplemental report(s) will be filed as any information becomes available.
Event or Problem Description
As reported for this event, the tip of the ultrasound probe was found to be missing at the time of preparation for an unknown event.There was no patient involvement.The device was not inspected before the start of set up.It is not known how the tip of the ultrasound came to be missing.There were no error messages, alarms, or alert tones associated with this event.The device was not dropped, nor did the device come in contact with a hard surface or sharp corner.The device is stored hanging in a scope cabinet and is cleaned after every use.
Additional Manufacturer Narrative
There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device had no dislodgement of the distal end at the time of shipment.It is likely that an external force was applied to the distal end region leading to the occurrence of the phenomenon.The instructions for use includes the following statements: 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: 11644100
• Report Number: 8010047-2021-04767
• Device Sequence Number: 19596082
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 03/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1