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

Model Number	BF-UC180F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide additional information regarding the reported event and the title of the contact personnel at the user facility.Please refer to the following sections of the form for the updated information.
Event or Problem Description
The user facility reported that they were performing an endobronchial ultrasound bronchoscopy (ebus) for biopsies to rule out cancer.There was a delay in the case while trying to remove the broken piece, maybe an extra 30 minutes.The tip of the scope that holds the balloon is what broke off, approximately 2mm.The doctor was able to remove the entire piece that was broken off from the patient.The patient is in good condition, discharged home after procedure.No demographics were provided.The scope was inspected prior to use by the endo staff and olympus rep.
Additional Manufacturer Narrative
The device referenced in this report was returned to olympus for evaluation.The device was visually inspected and found the distal probe tip broken off/missing, probe tip was not returned.In addition, the bending section cover was torn and failed the leakage testing.The bending section cover glue was cracked.There were broken image guide fibers noted during the evaluation.The angulation readings were low.The device was serviced and returned to the user facility.As part of our evaluation, the device instrument history was reviewed and it was noted that the scope was purchased on march 29, 2016 and found that no previous repairs done with the device.
Event or Problem Description
It was reported that at the end of a completed procedure, the flange from the distal end of the scope that held the balloon in place broke off and fell into a patient.There was no patient death, injury, or infection related to this event.The doctor was able to successfully extract the broken piece using a second scope.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information to mdr# 8010047-2020-03637.No device was returned to the original equipment manufacturer (omsc), however, an investigation was completed by omsc.The omsc performed a device history record review and no abnormalities were noted.Omsc determined that there was no manufacturing, material or processing related cause for this failure mode.The potential cause of the reported event has been determined to be excessive force/stress applied to the distal tip.To mitigate the risk of device damage, the instructions for use (ifu) please read before use section states, "do not apply shock to the distal end of the insertion section, particularly the ultrasonic transducer and the objective lens surface at the distal end.Visual abnormalities may result.".

• 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: 10196601
• Report Number: 8010047-2020-03637
• Device Sequence Number: 2973818
• 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: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2020

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: 06/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 08/05/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/03/2020; 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1