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

Model Number GIF-1200N

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the scope reprocessed due to overdue water filter replacement used in case.The issue occurred during an unknown event and 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 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 filter not being replaced was due to the device being reprocessed with the different procedure from the instruction manual.The event can be detected/prevented by following the instructions for use which state: ¿ instructions, operation manual for oer-6 chapter 7 ¿routine maintenance¿ section 7.3 ¿replacing the water filter (maj-2317)¿.The replacement frequency of the water filter was recommended in the instruction manual to be at least once in two months periodically as a guide.¿ olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18057243
• MDR Text Key: 327189430
• Report Number: 9610595-2023-16385
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-1200N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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
• Treatment: OER-6 ×2.MAJ-2317 ×2.