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

Model Number	BF-3C40
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the bronchofiberscope imaged looked blurry.The device was returned for evaluation.During testing and inspection of the device, the following reportable malfunction was found: light guide lens had foreign objects.There were no reports of patient harm or impact associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
E1.Establishment name: (b)(6).The device was returned to olympus for evaluation and in addition to the reportable malfunction documented in b5, the remaining evaluation findings were as follows: due to deformation of bending tube, connection between bending section and connecting tube was not secured; due to wear of angle wire, bending angle in up direction did not meet the standard value; due to a dent on channel tube, forceps and channel cleaning brush could not be inserted smoothly; control unit was sticky due to water leakage; control unit, grip, and scope cover had discoloration; image guide bundle had a stain; connecting tube and universal cord had a dent; adhesive on bending section cover had a chip; connecting tube had a wrinkle and buckling; light guide connector and universal cord had a scratch; and eyepiece was deformed.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and there were no obvious deviations from instructions for use (ifu) identified from review of the cleaning disinfection and sterilization (cds) steps provided by the customer.Therefore, the cause of the material remaining in the device could not be determined.The subject event can be detected and prevented by implementation in accordance with the below instructions for use.Instructions for bf- 3c40 series, operation manual, chapter 3 ¿preparation and inspection¿ describes how to detect the subject event.Instructions for bf- 3c40 series, reprocessing manual, chapter 3 ¿cleaning, disinfection, and sterilization procedures¿ describes how to prevent the subject event.Olympus will continue to monitor 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: 18643853
• Report Number: 9610595-2024-02457
• Device Sequence Number: 7316849
• Product Code: EOQ
• UDI-Device Identifier: 04953170339219
• UDI-Public: 04953170339219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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-3C40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2009
• 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