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

Model Number	BF-UC180F
Medical Device Problem Codes	Material Fragmentation (1261); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is ongoing to obtain additional information regarding the reported event.The device was returned to the service center for evaluation.A visual inspection was performed on the received device and found sharp edges on the control body.The scope failed the leak test due to damage on the bending section rubber glue and bending section rubber.Further inspection found chemical damage on the insertion tube of the scope.The bronchoscope instruction manual warns user on how to prevent damage to the scope.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.
Event or Problem Description
The service center was informed that during a procedure, foreign material was falling from the scope¿s channel.It is unknown if the intended procedure was completed.There was no patient injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation and to correct information provided on the initial report.The following sections were updated and/or corrected: g4, g7, h2, h4, h6, and h10.H10 of the initial mdr included information regarding a visual inspection that was performed on the received device which found sharp edges on the control body.It was also reported that the scope failed the leak test due to damage on the bending section rubber glue and bending section rubber.Further inspection found chemical damage on the insertion tube of the scope.Upon further review, these are not reportable malfunctions.Per the legal manufacturer, there is no potential for these issues to cause or contribute to death or serious injury if the malfunctions were to recur.Regarding the reported complaint of "foreign material was falling from the scope¿s channel", the complaint was not confirmed.During the evaluation and inspection of the device performed at an olympus service center, the repair technician was unable to see any debris in channel.Based on the legal manufacturer's investigation, the presence of debris reported by the customer may have occurred because foreign material may have adhered during the procedure that then subsequently fell off due to external force being applied.Multiple attempts were made to obtain more information from the customer regarding the procedure and the condition of the patient, but no additional information was provided.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.

• 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: 10881552
• Report Number: 8010047-2020-09273
• Device Sequence Number: 3315361
• Product Code: PSV
• UDI-Device Identifier: 04953170341823
• UDI-Public: 04953170341823
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 10/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1