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

Model Number BF-P290

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, after reprocessing the bronchovideoscope with oer-4 reprocessor, the scope had a green foreign substance attached to the distal part of the scope and connector.When other scopes were reprocessed, there was no adherence of foreign matter.So the customer determined that the issue was with the scope.The cleaning, disinfection and sterilization process followed onsite included primary cleaning followed by high level disinfection with oer-4 reprocessor.The same event has occurred once in the past, and this is the second occurrence.There was no patient involvement.Patient identifier: (b)(6) captures complaint on the previous occurrence.

Manufacturer Narrative

The customer provided response to the questionnaire regarding the presence of foreign material.The product was cleaned, disinfected, and sterilized before requesting repair.The customer does not know when the foreign material adhered to the scope.There was no delay to start of pre-cleaning.There were no problems with accessories used for reprocessing.The external surface of the endoscope was wiped with clean lint-free cloth, brush or sponge.The device was returned.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus and evaluated, and the reported phenomenon was confirmed.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, results of the water leakage test confirmed leakage from the biopsy channel.The actual item was disassembled to specify the cause of the event, and it was confirmed that inside the control section was rusted due to air leakage.As a result of checking inside the biopsy channel with an ultra-fine scope, it is confirmed that it was kinked as if folded.As a result of leakage from the biopsy channel and component analysis, it was possible that carboxylic acid and phosphoric acid were originated from medical agent, and copper oxide was rust from the part of the scope.The cause of the biopsy channel was kinked.It is likely that since there were not wrinkles nor buckling at appearance of the insertion tube of the scope and there were scratches inside the biopsy channel, the event occurred due to irregular insertion of accessories such as forcible insertion of accessories or brush, insertion/withdrawal of accessories while excessive loop state, insertion while opening the cup of the biopsy channel, insertion while the accessories were not sufficiently drawn into the sheath, forcible insertion of accessories while bending the device.The event can be detected/prevented by the user reading the ifu instruction manual and handle the device in accordance with ifu to prevent recurrence of the suggested event.The operation manual describes how to inspect for the subject event in ¿chapter 3 preparation and inspection¿ as below: "[3.3 inspection of the endoscope].3 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.10 if foreign objects, such as detergent remnants, hard water residue, finger grease, dust, and lint may be on the electrical contacts on the endoscope connector (ex.Wiping with lint-prone cloths, left unused for a long period of time), wipe the electrical contacts with clean lint-free cloths moistened with 70% ethyl or 70% isopropyl alcohol.Also, confirm that the electrical contacts are completely dry and clean.".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 16521519
• MDR Text Key: 311381043
• Report Number: 9610595-2023-04078
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-P290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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