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

Model Number BF-1T260

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 during the device inspection, that the bronchovideoscope exhibited peeling of the coating of the connecting tube.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.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.Based on the results of the investigation, it was likely that the peeling of the coating of the connecting tube event was caused by stress from repeated use, external factors, or handling of the device, leading to the malfunction.Based on the results of the investigation, it was likely that the no image event occurred due to the disconnection of the image sensor unit cable caused by a dent in the insertion tube, or a short circuit on the circuit board in the charged couple unit or the connector due to an air leak, leading to the malfunction.The "coating on the insertion tube was peeled off " issue is addressed in the instructions for use (ifu): 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.The "no image " issue is addressed in the instructions for use (ifu): important information ¿ please read before use precaution for 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.Precaution for disappeared or frozen endoscopic image; caution ¿ turn the video system center off before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope.Turn the switch on or off only when the videoscope cable is connected to both the video system center and electrical connector on the endoscope.Failure to do so can result in equipment damage, including destruction of the ccd.¿ do not touch the electrical contacts inside the electrical connector.Ccd damage may result.3.6 inspection of the endoscopic system inspection of the endoscopic image 4.While observing the palm of your hand, confirm that the examination light is output and that the endoscopic image is free from noise, blur, fog or other irregularities.5.Angulate the bending section and confirm that the endoscopic image is free from momentary disappearing or other irregularities.Chapter 5 troubleshooting if the endoscope is visibly damaged, does not function as expected or is found to have irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope.Contact olympus.Some problems that appear to be malfunctions may be correctable by referring to section 5.1, ¿troubleshooting guide¿.If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to olympus for repair.Olympus does not repair accessory parts.If an accessory part becomes damaged, contact olympus to purchase a replacement.If any abnormality in the function of the endoscope and/or endoscopic image is suspected during use, stop the examination immediately and carefully withdraw the endoscope from the patient as described in section 5.2, ¿withdrawal of the endoscope with an abnormality¿.Olympus will continue to monitor field performance for this device.

Event Description

It was observed during the device inspection, that the bronchovideoscope exhibited peeling of the coating of the connecting tube, a lack of image due to noise caused by deformation of the connector and damage to the imaging unit.There were no reports of patient involvement.

• Brand Name: EVIS LUCERA 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19109156
• MDR Text Key: 340907431
• Report Number: 9610595-2024-07915
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/25/2024

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
• Device Operator: Other
• Device Model Number: BF-1T260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2003
• 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