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

Model Number	BF-P150
Medical Device Problem Code	Peeled/Delaminated (1454)
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 bronchovideoscope had a leak from bending section cover.The issue was found during reprocessing.The device was returned for evaluation.During testing and inspection of the device, the following reportable malfunction was found: connecting tube had coating peeled.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
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 a cut on bending section cover, water tightness was lost; due to wear of angle wire, bending angle in up direction did not meet the standard value; connecting tube and plate had a dent; control unit had a scratch; light guide cover glass had a stain; and air/water leakage from the insertion tube/bending section.The investigation is ongoing.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.A review of the device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.Based on the results of the investigation, the root cause could not be identified.However, it is likely that the malfunction resulted from the following stress applied to the insertion section: ¿ physical stress such as scratching or hitting the insertion section.¿ chemical stress from conducting reprocessing not recommended in the instructions for use (reprocessing manual).¿ stress from poor storage environment (e.G., direct sunlight, high temperature, high humidity, exposure to x-rays, ultraviolet rays, etc.).The event can be [detected/prevented] by following the instructions for use which state: 3.2 inspection of the endoscope 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Olympus will continue to monitor field performance for this device.

• 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: 18670887
• Report Number: 9610595-2024-02774
• Device Sequence Number: 20657357
• Product Code: EOQ
• UDI-Device Identifier: 04953170288876
• UDI-Public: 04953170288876
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2016
• 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