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

Model Number GIF-HQ190

Device Problem Image Display Error/Artifact (1304)

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

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

During device evaluation at olympus, it was found the complaint was confirmed.Also, evaluation found the label was peeled/scratched, the id chip was unable to be checked due to a b30 error code, the instrument channel was leaking, the electrical safety test of the insertion tube failed, angulation was reduced, the control knob had play, the objective lens had third party repair, and multiple parts of the scope were non-olympus parts.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported that the image of the evis lucera elite colonovideoscope was fuzzy on the monitor.The issue was found when preparing the scope for use in a therapeutic procedure.There were no reports of patient or user harm associated with this event.  .

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, the root cause of the event was unable to be identified.It is likely that during user handling, the forceps channel leaked and flooded the interior of the instrument.The event can be detected/prevented by following the instructions for use which state: 1) "inspection of the endoscopic image." 2) "when inserting or withdrawing an endotherapy accessory, confirm that its distal end is closed or completely retracted into the sheath.Slowly insert or withdraw the endotherapy accessory 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." 3) "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." 4) "if the distal end of an endotherapy accessory is not visible in the endoscopic image, do not open the distal end or extend the needle of the endotherapy accessory.This could cause patient injury, bleeding, perforation, and/or equipment damage." 5) "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." 6) "troubleshooting guide : as repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 17012104
• MDR Text Key: 316756328
• Report Number: 9610595-2023-08119
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• 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