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

Model Number	BF-UC180F
Medical Device Problem Codes	Break (1069); Material Discolored (1170); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due diligence was executed for this event.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Device manufacture date is not known.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the probe unit tip of the device was broken; this is attributed to handling stress.The insertion tube had scratches and chemical damage.Incidental observations were there two consecutive ultrasound image elements broken, which is within acceptable standard.The charge couple device unit wire length was short.
Event or Problem Description
As reported for this event, during reprocessing the distal end of the device which holds the balloon had broken off.The procedure that had been performed was therapeutic and completed with no delay and with the same device.There was no harm or adverse impact to the patient.There were no other devices associated or replaced in the event.There was no visual deformation noted on the bending section of the scope.How the device was damaged is not known.The device is manually cleaned and put into the automatic reprocessor.There was no metal protruding and the bending section was not broken.The device is being leak tested after each use.
Additional Manufacturer Narrative
There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.The root cause cannot be conclusively determined.Likely cause is external force was applied by handling.For the damage to the insertion section, it could also have been chemical handling.The instructions for use includes the following statements: important information: please read before use: do not twist or bend the bending section with your hands.Equipment damage may result.¿ do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.¿ do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.

• 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: 10702278
• Report Number: 8010047-2020-07853
• Device Sequence Number: 19626764
• Product Code: PSV
• UDI-Device Identifier: 04953170341823
• UDI-Public: 04953170341823
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K070983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: No Information
• Device Model Number: BF-UC180F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1