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

Model Number BF-260

Device Problems Break (1069); Peeled/Delaminated (1454)

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 a broken charged coupled device unit and the connecting tube had coating peeling.There were no reports of patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.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, a definitive root cause of the observed damaged charged coupled device (ccd) unit, however, the issue was likely due to leakage at the insertion tube/universal cord, resulting in an ingress of water into the device and an electronic malfunction, and or damage to the ccd unit due to physical stress as a result of user handling/mishandling.Additionally, the insertion tube coating peeling issue could not be determined, however, the issue was likely due to physical stress such as rubbing or bumping, chemical stress due to reprocessing not in accordance with the ifu and or stress due to poor storage environment (direct sunlight, high temperature, high humidity, x-rays, ultraviolet rays, etc.).The event can be detected by following the instructions for use (ifu) which states: 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¿.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: 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: 18960192
• MDR Text Key: 338443033
• Report Number: 9610595-2024-06150
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K023984
• 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: 04/15/2024

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-260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2010
• 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