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

Model Number GIF-XP190N

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Date 08/18/2021

Event Type  malfunction  

Event Description

The customer reported an aspiration problem or air/water channel was blocked with a tissue like material.This was reportedly found during reprocessing.Olympus contacted the user facility to obtain more detailed information regarding this report, and was informed that there have been no reported injuries associated with this report.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation confirmed that the air/water flow from the nozzle was slow, as it did not clear the objective lens in 10 seconds, which is indicative of air/water channel being partially clogged.The device failed the leak test from the instrument channel.There was a customer's label on the light guide tube.There was a play on the control knobs movement.There were minor scratches noted on the distal end plastic cover.There were cuts on the switch #1 button.The device was serviced and returned to the user facility.The exact cause of the air/water channel being partially clogged cannot be conclusively determined at this time, as the legal manufacturer's investigation is ongoing.If additional and relevant information is received at a later time, this report will be updated accordingly.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation results.Based on the initial evaluation, there was insufficient angulation range.The subject device was not repaired in the past year.A review of the complaint database did not find similar complaint from the same user facility in the past.A review of the dhr confirmed that the device meets all manufacturing specifications and final product release criteria.Based on the labeling review there was no information provided on obvious misuse.The reported event was not due to product design.The root cause could not be specified, as there was no confirmation of the presence of a foreign material being lodged in the nozzle, no physical damage found in the nozzle or air/water channel during the physical evaluation of the device, and the user facility was unable to provide more detailed information regarding the reported event.However, based on the evaluation findings of the returned device, user handling and improper maintenance of the device cannot be ruled out as a contributory factor to the reported event.

• 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: 15822806
• MDR Text Key: 307905521
• Report Number: 9610595-2022-04200
• Device Sequence Number: 1
• Product Code: FDS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2016
• 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