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

Model Number	BF-UC180F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during the reprocessing at user facility, it was found that the detachment of the instrument channel port from the subject device.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was not returned to omsc for evaluation, therefore omsc could not investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined, however based on the reported information from olympus australia, there was the possibility that this phenomenon was attributed to following.The excessive stress was applied to the instrument channel port while inserting the endotherapy accessory or the cleaning brush to the instrument channel port, then the instrument channel port might become deteriorated and loosened.Consequently the external force was applied while reprocessing, the instrument channel port might be detached.If additional information becomes available, this report will be supplemented.

• 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: 10394916
• Report Number: 8010047-2020-05443
• Device Sequence Number: 2744013
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2020

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: No Information
• Device Model Number: BF-UC180F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1