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

Model Number	BF-Q180
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the service center for evaluation.As part of our investigation, the ess performed a reprocessing in-service that included demonstrating reprocessing steps for the bf-q180 in accordance with manufacturer¿s recommendations.The ess also, reported that the facility¿s sterile processing staff was informed of the scope¿s pre-cleaning requirements to ensure it has been completed prior to leak testing and manual cleaning.The scope was not returned for evaluation.The instruction manual ¿reprocessing before the first use/reprocessing and storage after use¿ section states ¿after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual.Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance.¿.
Event or Problem Description
The service center was informed that during a reprocessing in-service with an endoscopic support specialist (ess) at the customer¿s site the scope was improperly reprocessed.The ess reported that the facility¿s sterile processing does not perform the pre-cleaning steps.Also, that the facility was not completing suction following the brushing of the suction cleaning adapter.There was no patient involvement, patient infections or device positive cultures reported.

• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10597098
• Report Number: 8010047-2020-06941
• Device Sequence Number: 13751012
• Product Code: EOQ
• UDI-Device Identifier: 04953170339301
• UDI-Public: 04953170339301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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-Q180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1