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

Model Number GIF-1TH190

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

A user facility reported to olympus that the evis exera iii gastrointestinal videoscope had a missing air/water nozzle.The event occurred during preparation for use, prior to an unknown procedure.Upon inspection and testing of the customer returned device, foreign material was found clogged in the scope air/water channel 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

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the customer returned device the following defects were found, scope case unit deformed, distal end cover discolored, objective lens cracked, light guide lens cracked, adhesive on angle rubber worn, connecting tube deformed, due to wear of angle wire, bending angle in down direction did not meet the standard value, due to deformation of bending tube, bending angle in right direction did not meet the standard value, and due to damage on biopsy tube, forceps could not be inserted smoothly.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.

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 identity and definitive root cause of the foreign material could not be determined.The instruction manual describes verbiage associated with the detection and prevention of issues during reprocessing.It is possible that the looseness of the air pipe due to the deformation of the connector caused the reprocessing accessories to be improperly assembled, which may have resulted in foreign material not being removed.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received that the reported error was detected on january 27,2023 by an olympus service technician during on-site service.In addition, the event date is before jan 25, 2025.

Manufacturer Narrative

This report has been submitted to provide correction to the initial report id: 9610595-2023-02764 submitted on feb 17, 2023.Correction: the correct aware date (g3) for the initial report id: 9610595-2023-02764 submitted on feb 17, 2023 is jan 27, 2023.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• 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: 16400353
• MDR Text Key: 310234886
• Report Number: 9610595-2023-02764
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2018
• 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