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

Model Number	BF-UC180F
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A reprocessing in-service with staff was performed.During in-service, customer informed the endoscopy support specialist (ess)that they use bw-400v instead of bw-400b for the bf-uc180f.All models reviewed during the in-service, which included the cleaning and disinfecting information.Recommended customer follow all olympus reprocessing procedures as documented in the ontrack forms and reprocessing manuals.No further information was reported.
Event or Problem Description
The customer reported to olympus that a reprocessing in-service was needed.There was no patient injury reported.
Additional Manufacturer Narrative
The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to improper handling by the user.Based on the available information, it was confirmed that the reprocessing was performed by use of bw-400v in place of bm-400b which was specified in instructions for use.Therefore, it is inferred that the reprocessing was not performed appropriately.According to the product standard, bw-400b is different only in the length of its wire from bw-400v.However, it is recommended to perform the reprocessing procedure by use of the instrument specified in ifu.

• 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: 10273371
• Report Number: 8010047-2020-04407
• Device Sequence Number: 19645065
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: Health Professional
• Device Model Number: BF-UC180F
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1