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

Model Number BF-1TQ170

Device Problems No Display/Image (1183); Peeled/Delaminated (1454); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device inspection, the bronchovideoscope exhibited peeling on the coating of the connecting tube, image loss due to foreign material and corrosion on the electric contact, and foreign material was found in the air/water channel.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field: d5.For events "coating at insertion section peeled off" and "no image": a review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.For event "foreign material in channel": a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over eight (8) years since the subject device was manufactured.Based on the results of the investigation, it is likely the following led to the malfunction: -for event "coating at insertion section peeled off": the following stress may have been applied to insertion section, which led to occurrence of the suggested event.·physical stress such as scratching, hitting the insertion section ·chemical stress by conducting reprocessing which is not recommended by instructions for use (reprocessing manual).·stress by poor storage environment (in direct sunlight, at high temperatures, in high humidity, exposed to x-rays and/or ultraviolet rays, etc.) -for event "no image": it is presumed from the following investigation results that the event occurred by electrical continuity failure due to water invasion of the device, electrical contacts of scope connector being dirty, breakage of circuit board, breakage of image sensor unit, etc.-for event "foreign material in channel": reprocessing may have not been conducted properly by water leakage of the device.Subsequently, the material was not possibly eliminated.The legal manufacture was unable to confirm whether the customer's reprocessing steps were deviated from the instructions for use.Based on the results of the investigation, olympus confirmed foreign material came out of the device, but the type of the material or root cause cannot be identified.The event can be detected and/or prevented by following the instructions for use which state: -for event "coating at insertion section peeled off": 3.3 inspection of the endoscope 5 inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.-for event "no image": important information ¿ please read before use ¦warnings and cautions: caution turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor.¦warnings and cautions; disappeared or frozen endoscopic image: warning follow the precautions given below.Otherwise, the endoscopic image may disappear unexpectedly, or the frozen image may not be restored during the examination.3.8 inspection of the endoscopic system ¦inspection of the endoscopic image confirm that the wli and nbi endoscopic images are normal.5.1 troubleshooting if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Olympus will continue to monitor field performance for this device.

• Brand Name: BRONCHOVIDEOSCOPE
• Type of Device: 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19203880
• MDR Text Key: 341926366
• Report Number: 9610595-2024-08858
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170342943
• UDI-Public: 04953170342943
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TQ170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1