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

Model Number BF-1TQ290

Device Problem Break (1069)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's reported issue ¿distal end is broken¿ was confirmed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported to olympus that the evis lucera elite bronchovideoscope the distal end is broken found during reprocessing.Upon inspection and evaluation, the plastic distal end cover was burnt.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during incoming inspection and evaluation.

Manufacturer Narrative

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, it is likely when the user was performing high-frequency cauterization they came in contact with mucosa and did not push an endo therapy accessory out to the visible position of the green marking in sheath of the accessory, and electrified without contacting electrode of an endo therapy accessory with mucosa.As a result, the distal end was burnt.However, a definitive root cause could not be determined.Instructions for use provides (ifu) the following warnings for high-frequency cauterization of the operation manual.Chapter 4.3 "using endo therapy accessories" warning.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.Always confirm that the electrode section of the electrosurgical accessory is at an appropriate distance from the distal end of the endoscope.Confirm that the entire green marking (in case of wli observation mode) at the distal tip of the electrosurgical accessory can be observed on the endoscopic image.If the electrode is used when it is too close to the distal end of the endoscope, the endoscope and/or ancillary equipment may be damaged.Patient injury, burns, bleeding, perforation, and/or equipment damage may result.Be sure to contact the electrode section of the high-frequency endo therapy accessory with tissue when performing high-frequency cauterization treatment to prevent equipment damage and operator and/or patient burns." additionally, the instructions for use provides (ifu) provides the following warnings for high-frequency cauterization.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." 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: 18051681
• MDR Text Key: 327141219
• Report Number: 9610595-2023-16327
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TQ290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• 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
• Treatment: CV-290