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

Model Number GIF-H185

Device Problems Material Deformation (2976); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, that the evis exera iii gastrointestinal videoscope had presented with too much pressure.There were no reports of patient harm associated with this event.During the evaluation of the device, it was noted, that the nozzle was clogged with foreign material.The foreign material remained in the nozzle, which can cause insufficient reprocessing.The foreign material could not be removed even if the correct reprocess was performed, due to the buckling of each channel nozzle.This report is to capture the reportable malfunction of foreign material in the nozzle that could not be removed, due to buckling that was noted at estimation.

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the allegation was confirmed.Additional issues were identified during the device evaluation:the angle wires were stretched, the adhesive part on the bending rubber was worn out, part of the insertion tube was caught and pinched, the insertion tube becomes deformed, the light guide lens was cracked; due to a shock caused by dropping and knocking the endoscope to a hard surface or object.A crack in the resin part, the parts secured in the unit became loose; due to degradation for a long duration.And defects on the universal cord.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.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 observed foreign matter in the nozzle appeared to be a crystalline material, possibly a cleaning agent residue, but otherwise could not be identified.A definitive root cause of the issue could not be determined, as the facility device reprocessing was reported to have been implemented in accordance with the ifu and no device deformation was observed that might contribute to the retention of foreign material, however, the issue was likely the result of improper user handling/device reprocessing.The event can be detected by following the instructions for use sections below: inspection of the air-feeding function; inspection of the objective lens cleaning function.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: 16923695
• MDR Text Key: 315468016
• Report Number: 9610595-2023-07431
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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