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

Model Number	BF-UC180F
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device was visually inspected which identified the tip of the brush was stuck in the balloon channel.The cause cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.
Event or Problem Description
It was reported the device was returned due to a crack at the tip.During estimation, it was identified that there was no ability to pass the small brush through the balloon channel.No patient injury occurred.
Additional Manufacturer Narrative
This report is being supplemented to provide the legal manufacturer¿s investigation summary regarding this report.From the information provided during complaint initiation, the following was confirmed: it was confirmed that the brush tip was stuck in the balloon channel, and that there was no description of the type of brush used.A review of the product labeling provides the following information: in regard to the brush, confirming the contents of the ifu which was provided during delivery of the product, the following description was found.All items mentioned below are single-use items.Do not clean, disinfect, or sterilize the equipment prior to use and/or after use.Doing so may damage the equipment.Using damaged equipment may make it difficult to effectively reprocess the endoscope, and could cause endoscope and/or equipment damage.Mh-507,bw-411b, and maj-1339.This is an event that occurred during reprocessing, not during a procedure.Although the true cause has not been identified because this event was confirmed based on the image and information alone, the following is presumed: the image shows that the brush tip has been stuck in the balloon channel and is broken.In brushing the balloon groove during reprocessing, the brush tip may have been stuck in the balloon channel.When the brush tip was stuck in the balloon channel, the brushing force may have been applied, resulting in the breakage of the brush.The type of brush used this time is unknown.If this event occurred using a brush other than the recommended brush (mh-507,bw-411b,maj-1339) described in the instruction manual, the safety and cleaning efficacy of bf-uc180f cannot be assured.

• 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: 10486461
• Report Number: 8010047-2020-06125
• Device Sequence Number: 11404916
• Product Code: PSV
• UDI-Device Identifier: 04953170243226
• UDI-Public: 04953170243226
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 06/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1