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

Model Number	BF-UC180F
Medical Device Problem Codes	Device Reprocessing Problem (1091); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.The customer¿s complaint of ¿foreign material/debris were falling off from the channel working channel and it was coming apart.Also, a red dye like substance was in the channel¿ was partially confirmed.Scratches were noted inside was the forceps passage.The root cause of the reported event cannot be determined at this time.The instruction manual provides warnings to prevent channel damage: chapter 4.Withdrawal of endotherapy accessories do not withdraw the endotherapy accessory if the tip is open or extended from its sheath; patient injury and/or instrument damage may occur.The investigation is ongoing and if additional information is received this report will be supplemented accordingly.
Event or Problem Description
The service center was informed during reprocessing the scope¿s working channel was coming apart with debris noted inside the channel.There was also a red dye like substance in the channel.There was no patient involvement reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, although the foreign material could not be identified, it is likely tissue from the previous patient.It is possible the pressure difference between the patient's body cavity and the scope caused the patient's blood and tissue to flow back into the channel.It is possible that due to the damage inside the forceps channel, the cleaning at the facility after the case was insufficient and the foreign matter inside the forceps channel could not be completely cleaned and remained.The damage inside the forceps channel is likely to have been caused by damage to the inside during a puncture procedure or by impact caused by hitting the device.The following details to prevent channel damage are described in the device's instructions for use under section "4.3 using endotherapy accessories": "insertion of endotherapy accessories into the endoscope caution do not open the tip of the endotherapy accessory or extend the tip of the endotherapy accessory from its sheath while inserting the endotherapy accessory into the instrument channel.The instrument channel and/or the endotherapy accessory may become damaged."."withdrawal of endotherapy accessories warning do not withdraw the endotherapy accessory if the tip is open or extended from its sheath; patient injury and/or instrument damage may occur.".

• 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: 11385756
• Report Number: 8010047-2021-03053
• Device Sequence Number: 11624012
• Product Code: PSV
• UDI-Device Identifier: 04953170355608
• UDI-Public: 04953170355608
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 02/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1