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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no additional information available for this event as yet.Event date is not known.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, the device probe unit tip was found to be broken.Ultrasound image had elements broken as well.In addition, the angulation had some play.Evaluation is still ongoing.Supplemental report(s) will be filed as any information becomes available.
Event or Problem Description
As reported for this event, during an unknown procedure, the ultrasound tip of the device was observed to have the little bold piece missing.There is no reported harm or adverse impact to the patient.
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 has no abnormality in manufacturing, concession, and variation.There is no available repair history for this device.Aging deterioration was excluded as a reason for the broken probe unit tip judging by the year of manufacture of the device.Confirming that the phenomenon is not prone to occur, it is attributed to the user¿s handling.The instructions for use includes the following statements: chapter 3 preparation and inspection before each procedure, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as described in their respective instruction manuals.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 10.3, returning the endoscope for repair on page 149.If any irregularities are suspected after inspection, follow the instructions given in chapter 10, troubleshooting.

• 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: 11812213
• Report Number: 8010047-2021-06202
• Device Sequence Number: 3149542
• Product Code: PSV
• UDI-Device Identifier: 04953170341823
• UDI-Public: 04953170341823
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 04/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1