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

Model Number GIF-XP190N

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

During the device evaluation, there was a minor dent and wrinkle in the insertion tube.Multiple deep dents with sharp edges were observed at the distal end, and the ce label required replacement.The investigation is ongoing; therefore, a root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that the evis exera iii gastrointestinal videoscope water channel was not working (no air/water flow).The issue was found during preparation for use.There was no patient or user harm associated with the event.The subject device was returned to olympus for evaluation.During inspection and testing, it was found that there was no air or water flow due to foreign material clogging the air/water nozzle.This report is being submitted for the presence of foreign material found during the device 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, the observed foreign material clogging nozzle could not be identified and a definitive root cause of the issue could not be determined, as there was no reported device deformation that could contribute to the retention of foreign material and no additional facility device cleaning/reprocessing information was reported or available, however, the issue was likely the result of insufficient device cleaning/reprocessing.The event may be detected/prevented by following the instructions for use sections below: gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope 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: 17511113
• MDR Text Key: 321073645
• Report Number: 9610595-2023-11553
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305313
• UDI-Public: 04953170305313
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123317
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP190N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2013
• 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