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

Model Number GIF-H185

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the lock mechanism for the right/left knob was permanently engaged and could not be disengaged on the videoscope.There were no reports of patient involvement.

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.It has been over eight (8) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that right/left angulation control knob engaged and cannot be disengaged occurred because the angulation system inside control section corroded due to the bending section cover, plug unit and universal cord had leakage.The event can be detected by handling the device in accordance with the following instructions for use : operation manual_ inspection of the endoscope_ inspection of the bending mechanisms reprocessing manual_ leakage testing of the endoscope_ perform the leakage test if you identify a leak during leakage testing, remove the endoscope from the water with the leakage tester still attached.Contact olympus regarding instructions for reprocessing a leaking endoscope in preparation for returning the endoscope to olympus for repair.Olympus will continue to monitor field performance for this device.

• 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: 18990300
• MDR Text Key: 338777107
• Report Number: 9610595-2024-06498
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: LH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GIF-H185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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