MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

Model Number	BF-UC180F
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoscopy support specialist (ess) provided a reprocessing in-service/reprocessing training to the user facility staff.The ess provided the user facility staff reprocessing training materials for their reference.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus was informed that during an onsite visit, the user facility staff used a 10ml syringe instead of a 30 ml syringe to reprocess a bronchofibervideoscope.No patient infections or injuries reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: g2 company representative should be deselected and health care professional should be selected on the initial medwatch.H4 of the initial report was corrected, please see h4 for further details.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, and since the device was not returned for evaluation, the root cause could not be conclusively identified.However, it is likely that the customer used a 10ml syringe for flushing the balloon channel instead of 30ml syringe per the instructions for use.The instructions for use states the prevention methods associated with the event in instructions evis exera ii ultrasonic bronchofibervideoscope olympus bf type uc180f chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Common Device Name: ULTRASONIC BRONCHOFIBERVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19560720
• Report Number: 3002808148-2024-05545
• Device Sequence Number: 4850591
• Product Code: PSV
• UDI-Device Identifier: 04953170243233
• UDI-Public: 04953170243233
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown