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

Model Number	BF-UC180F
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.A visual inspection was performed on the returned device and found a dent on the probe unit tip.The bending section glue was cracked on the insertion tube and cover.The image was tested and the scope¿s eyepiece was found damaged and there were 2 broken elements noted in the ultrasound image.Further inspection found cuts, scratches, discoloration and chemical damage on the insertion tube.Scratches on the surface of the light guide tube were also noted.The estimator attributed the damage to wear and tear.However, the legal manufacturer will review the content of this complaint for further evaluation.
Event or Problem Description
The service center was informed that during an unspecified procedure, the doctor punctured a hole, with a needle, on the distal end by the tip.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the additional information.Please the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.The legal manufacturer reported that the most probably cause for the reported event is the following: regarding the perforation of the forceps channel, it was confirmed that the physician had drilled the hole with the needle based on the raised information, so it was caused by the application of external forces due to handling.Damage to the insertion part may have occurred due to external forces or handling by chemicals, because fine scratches and discoloration have been observed.
Additional Manufacturer Narrative
This supplemental report is submitted to provide additional information related to the device evaluation and investigation.Inspection of the returned device found evidence of cuts, scratches, discoloration and chemical damage on the insertion tube.An investigation determined that the observed damage to the insertion tube was likely a result of user handling.In addition, the legal manufacturer determined that the reported puncture to the distal end of the tip is attributable to user handling.As stated in the instructions for use, as a preventive measure: "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: 10778876
• Report Number: 8010047-2020-08464
• Device Sequence Number: 16416041
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2021

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: 09/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 01/26/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/31/2020; 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1