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

Model Number GIF-HQ190

Device Problem Image Display Error/Artifact (1304)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and customer allegation was confirmed.After aeration, the error e216 / image issue was resolved.There were multiple buckles on the insertion tube and instrument channel.There was no data on the device due to noisy image.Scratches were noted on the distal end cover.The edge of the objective lens was chipped off.Cracks were noted on the light guide (lg) lens.The insertion tube glue, grip and lg tube was buckled.Angulation was low and control knob had play.There was trace of water invasion in the scope connector and instrument channel.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The customer reported to olympus, when evis exera iii gastrointestinal videoscope was put on the tower, the light started to dim and then came back to full light after which the device displayed a white fuzzy screen.It was also reported that the bending sheath was wrinkled.There were no reports of patient harm associated with the event.

Event Description

It was further reported, the issue was observed before procedure.The intended procedure was esophagogastroduodenoscopy (egd).There were no other devices involved in the event.There was no delay in the procedure.The procedure was completed with a similar device.

Manufacturer Narrative

This report is being submitted for additional information provided by the customer.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.

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; however, the event likely occurred due to the moisture that entered the inside of the device from the leak point.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to correct the product code for the subject device from fdf to fds.See section d2.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO GASTRODUODENOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15830095
• MDR Text Key: 307889890
• Report Number: 9610595-2022-04295
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• 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: 10/27/2022
• 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: 06/10/2016
• 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