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

Model Number BF-1TH190

Device Problems Device Reprocessing Problem (1091); No Display/Image (1183)

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

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.And the customer¿s allegation regarding image blacked out was confirmed.However, the reference to the foreign material falling from the nozzle was not confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: id chip has no data transmission, leak from instrument channel, liquid inside light guide lens, flickering image, bending section has excessive frayed wires, and connector has fluid invasion.The investigation is pending.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, that the evis exera iii bronchovideoscope had foreign material falling off from the channel black liquid coming out of scope during reprocessing.During inspection and evaluation, foreign material was falling from the nozzle and the image blacked out.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 malfunctions 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.It has been more than 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the biopsy channel leaked causing foreign material to not have been removed during reprocessing.Water invaded the scope connector and likely caused damage to electronic parts resulting in image issues.However, a definitive root cause could not be determined.The user may detect the "image blacked out" event by handling the device in accordance with the following ifu: "inspection of the endoscopic image - when inserting or withdrawing an endotherapy accessory, confirm that its distal end is closed or completely retracted into the sheath.Insert or withdraw the endotherapy accessory slowly and straight into or from the slit of the biopsy valve.Otherwise, the biopsy valve or instrument channel may be damaged and pieces of it could fall off.It may cause patient injury.If insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.Perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk." the user may reduce/prevent the occurrence of the "black liquid from the device" by handling the device in accordance with the following ifu: "when inserting or withdrawing an endotherapy accessory, confirm that its distal end is closed or completely retracted into the sheath.Insert or withdraw the endotherapy accessory slowly and straight into or from the slit of the biopsy valve.Otherwise, the biopsy valve or instrument channel may be damaged and pieces of it could fall off.It may cause patient injury.If insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.Perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 16778149
• MDR Text Key: 313669628
• Report Number: 9610595-2023-06417
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335181
• UDI-Public: 04953170335181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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