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

Model Number	BF-UC180F
Medical Device Problem Codes	Material Puncture/Hole (1504); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation/service.The evaluation did not confirm the customer's complaint of blockages and restrictions in the instrument channel, as during the evaluation there was no restrictions or blockages noted in the instrument channel.The device was visually inspected and observed a hole in the channel.There was one broken element in the ultrasonic image.The c-body contained chips and scratches.The channel was scraped due to repeated insertion and withdrawal of brush and endotherapy accessories.The creation of the hole is due to excessive stress and force.There was no patient involvement.No additional information was made available at this time.The instruction manual states ¿inspect the entire surface of the scope for dents, protrusions, or other irregularities.Feel the entire shaft with fingers, checking for irregularities.Do not use if damage is found.¿ the device was serviced and returned to the user facility.
Event or Problem Description
The user facility returned the device for service due blockages and restrictions in the instrument channel.The user facility was contacted to obtain additional information regarding the reported complaint and was informed that there was no patient involvement and no patient injury associated with this report.No additional information was provided.
Additional Manufacturer Narrative
Evaluation found that bx channel was not confirmed with hole in channel.Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 10141163
• Report Number: 8010047-2020-03256
• Device Sequence Number: 14033042
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1