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

Model Number GIF-EZ1500

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Event Description

The customer reported that the flex video scope had reduced angulation, and there was an image issue.No patient or user injury was reported.The subject device was received at an olympus service center for evaluation.During inspection and testing, foreign material was found stuck in the nozzle.This report is being submitted for the malfunction found during the device evaluation.

Manufacturer Narrative

During the device evaluation, the bending angle in the up direction did not meet the standard value due to wear of the angle wire.Due to wear of the angle wire, the play of the up/down knob was out of standard value.Due to damage to the charge coupled device (ccd) unit, the image sensor was damaged, and the brightness was uneven.The adhesive on the bending cover (a-rubber), around the objective lens, and around the light guide lens, was cloudy.The adhesive on the a-rubber was chipped.The camera cover (c-cover) and the connecting tube were scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to h10 (reprocessing of subject device), this information was inadvertently not included on the initial medwatch.The customer did not clean, disinfect, or sterilize the device before sending it back to olympus.They did not flush the air/water nozzle with water and air.There were no abnormalities in the accessories used for reprocessing.They did not flush the air/water nozzle with the detergent solution.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the root cause could not be determined.It was confirmed that foreign material was in the nozzle, however, the specific material could not be identified and the cause of the material remaining in the device could not be specified.The air water nozzle was not deformed, and it is likely that the foreign material remained since the reprocessing deviated from the ifu.The following information is stated in the instructions for use (ifu): ¿[inspection of the endoscope] 9 inspect the air/water nozzle at the distal end of the endoscope for any irregularities such as abnormal swelling, bulges, and dents.¿inspection of the objective lens cleaning function] inspection of the water feeding function 1 cover the spray valve hole with your finger.2 depress the valve all the way (till the 2nd step) and confirm that water flow is observed in the entire endoscopic image.¿ 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: 16975705
• MDR Text Key: 316102241
• Report Number: 9610595-2023-07825
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-EZ1500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• 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