MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES BRONCHOFIBERSCOPE

Model Number	BF-P60
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that during reprocessing by staff of a bronchofiberscope, it was reported that insufficient reprocessing occurred, as the scope was processed without the ethylene oxide gas valve cap in place.No patient infections or injuries reported.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over six (6) years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint that the scope was processed without the ethylene oxide gas valve cap in place was not confirmed.Based on the results of the investigation and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.We considered that the user¿s understanding of device handling and reprocessing steps was different from the recommendation by olympus.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use: ¿ifu states preventive measures in bf-p60 reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.¿ olympus will continue to monitor the field performance for this device.

• Brand Name: OES BRONCHOFIBERSCOPE
• Common Device Name: BRONCHOFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19266852
• Report Number: 9610595-2024-09323
• Device Sequence Number: 7355934
• Product Code: EOQ
• UDI-Device Identifier: 04953170339196
• UDI-Public: 04953170339196
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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-P60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2017
• 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