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 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, distal end cover insulation cracked, insertion tube scratches/dented, light guide tube scratched, distal end cover cracked, objective lens/light guide lens glue worn/chipped, scope nozzle clogged, and angle rubber glue cracked.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A user facility reported to olympus that during reprocessing of the evis exera iii gastrointestinal videoscope, the scope air/water channel was blocked.Upon inspection and testing of the customer returned device, foreign material was found clogged in the scope air/water nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following fields were corrected: g2 was corrected to include company representative, as the reportable malfunction occurred during device evaluation.The h4 device manufacturing date was missing from the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 2 years since the subject device was manufactured.Based on the results of the investigation, the foreign material could not be identified, nor a specific root cause for the foreign material identified.The event can be detected and prevented by following the instructions for use: instruction manual gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection shows how to detect the event.Instruction manual gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope shows how to prevent the event.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: 16490132
• MDR Text Key: 311383591
• Report Number: 9610595-2023-03801
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

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: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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