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

Model Number	BF-1TH1100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the bronchovideoscope's biopsy channel became loose during an unspecified procedure.The intended procedure was completed.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
Updated: h3, h6, h11.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.Based on the results of the investigation, the reported loose biopsy channel was confirmed and found to be due to the rubber cover and the rotation stop key that secure the base had come loose.A definitive root cause of the issue could not be determined; however, the issue was likely due to repetitive use stress as a result of connecting and disconnecting the disinfection adapter tubing to the instrument channel port, and or may either be an endotherapy accessory.Additionally, a definitive root cause of the observed burn on the plastic distal end cover could be determined, however, it is likely that a high-energy treatment tool (e.G.High-frequency cauterization, laser cauterization, or argon plasma coagulation) was used and device misuse likely occurred in one or more of the following ways: -when using high frequency treatment tools: a.The tip of the endoscope was in contact with the mucous membrane.B.The treatment tool was not extended to a position where the green indicator on the sheath of the treatment tool was visible.C.Output was generated without the electrodes of the treatment tool touching the tissue.-when using a laser cauterization device: laser cauterization treatment was performed without having to move too far from the tip of the device, so that the tip of the laser probe was clearly visible in the endoscopic image.When using an argon plasma cauterization device: the argon plasma coagulation probe was not extended to a position where the black ring at the tip of the probe was visible in the endoscopic image (more than 10 mm).The event may be detected/prevented by following the instructions for use which state: 1.The ifu (operation manual) instructs pre-use inspection in the following sections and warns against using equipment with abnormalities in cases.Chapter 3 preparation and inspection:3.1 the workflow of preparation and inspection: before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5,¿troubleshooting¿.If the endoscope malfunctions, do not use it.Warning: never use the endoscope on a patient if any irregularity is observed.The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage.In addition, it may pose an infection control risk.The ifu states the following warnings when performing radiofrequency ablation: -operation manual chapter 4.3using endotherapy accessories always confirm that the tissue is an appropriate distance away from the distal end of the endoscope.If high-frequency cauterization is performed when the distal end of the endoscope contacts the tissue, patient injury, burns, bleeding, perforation, and equipment damage may occur.3.The ifu states the following warnings when performing laser ablation: to avoid patient injury, burns, bleeding, perforation, and/or damage to the endoscope, never emit laser radiation before confirming that an appropriate distance between the target and the endoscope¿s distal end is maintained and the tip of the laser probe is surely in the correct position in the endoscopic image.4.The ifu states the following warnings when performing argon plasma cauterization (apc): make sure that the distal end of the apc probe always lies more than 10 mm from the endoscope¿s distal end (see figure 4.9).The protrusion by 10 mm or more can be identified when the first black ring on the apc probe¿s distal end is visible in the endoscopic image.Otherwise, the treated region cannot be irradiated correctly and the endoscope may be damaged.Using a damaged endoscope may cause patient injury.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: 20350781
• Report Number: 9610595-2024-19838
• Device Sequence Number: 15459818
• Product Code: EOQ
• UDI-Device Identifier: 04953170424199
• UDI-Public: 04953170424199
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K222861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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-1TH1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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