MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOVIDEOSCOPE

Model Number	BF-P150
Medical Device Problem Codes	Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected data: h6 (medical device problem code: adding ¿component missing¿).This report is being supplemented to provide additional information based on 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 13 years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined, however, it is likely physical stress was applied to biopsy port and distal end during user handling.The event can be prevented by following the instructions for use which states: ¿do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.¿.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported the bronchovideoscope was missing a distal cover and the biopsy port had incomplete accessories.The issues were discovered at reprocessing.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• 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: 20362362
• Report Number: 9610595-2024-20016
• Device Sequence Number: 18573928
• Product Code: EOQ
• UDI-Device Identifier: 04953170288876
• UDI-Public: 04953170288876
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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-P150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2011
• 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