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

Model Number GIF-2T200

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

The manufacture date of the subject device cannot be identified since the storage period of the device history record (dhr) is 15 years and the storage period of the dhr for the subject device has expired.The device was not returned.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The customer contacted olympus to determine if the tube used for cleaning and disinfecting the gif-2t200 in the oer-3 was correct.The company representative visited the site and confirmed that the site did not have maj-1504 and maj-1505 among the four necessary cleaning tubes.According to the facility, they have been using maj-1500 and maj-1971 for some time.The site was advised to purchase the missing tubes.This report is being submitted to capture the complaint on scope that was reprocessed by following incorrect procedure.The intended procedure was endoscopy.The procedure was completed with the same device.There were no reports of patient harm associated with the event.Patient identifier (b)(6) captures complaint on reprocessor (model: oer-3, description: olympus endoscope reprocessor, serial no.(b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Based on the results of the investigation, the root cause of the missing tubes needed for reprocessing per instructions for use could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS 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: 16120568
• MDR Text Key: 308714969
• Report Number: 9610595-2023-00379
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-2T200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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