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

Model Number GIF-H185

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Event Description

The customer reported the evis exera iii gastrointestinal videoscope bending rubber was worn, the angled part was dented, and the charge coupled device (ccd) lens was broken at its edge.The device was returned to olympus medical for evaluation.During inspection, the returned device was found to have foreign material on the bending rubber adhesive.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No adverse effects to patient reported.

Manufacturer Narrative

During evaluation, the bending rubber adhesive showed it was separating at the thread-wound sections which allowed foreign material to collect at that area.Additionally, the objective lens was cracked.The device failed leak testing due to damage to the scope channel; the angulation knobs had excess play; the suction cylinder color indicator had worn off; switch button 1 was scratched; the light guide lens was chipped; the bending tube was deformed; and the connecting tube was scratched.The device did not meet the electrical insulation standards at the distal end or at the connector cover.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 root cause of the reported event is unable to be determined.However, the cause of the event is likely due to imperfection of proper reprocessing caused by leakage.The event can be detected by following the instructions for use (ifu) section which state: 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: 17424377
• MDR Text Key: 320046118
• Report Number: 9610595-2023-10832
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 07/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2018
• 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