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

Model Number GIF-H185

Device Problems Device Reprocessing Problem (1091); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that the evis exera iii gastrointestinal videoscope had an angulation locking malfunction.There were no reports of patient harm or impact associated with the reported event.

Event Description

Additional information was received noting that the device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the plastic distal end cover, the scope connector cover unit, the scope connector case and the air/water cylinder all has foreign objects.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.Correction to event description, component codes, and medical device problem code.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.During the evaluation it was found that the scope connector cover unit has foreign objects, the scope connector case unit has foreign objects, and the plastic distal end cover has foreign objects.Additional findings were as follows: the scope body has a crack, due to damage on up/down knob, water tightness is lost, the air/water cylinder has foreign objects, the suction cylinder has discoloration, the forceps channel port has corrosion, the control unit is dirty due to water leakage, there was no scope id data (circuit board), the plug unit is deformed, the light guide cover glass has corrosion, the scope connector case unit has corrosion due to water leakage, the plug unit has corrosion due to water leakage, the label on scope connector is damaged, due to damage on channel tube, water tightness is lost, due to a chip on plastic distal end cover, insulation resistance value at distal end does not meet the standard value, the plastic distal end cover has a crack, a third party repair has been performed on the plastic distal end cover, the objective lens, the light guide lens has a crack, a third party repair has been performed on the light guide lens, the connecting tube has a cut, and a third party repair has been performed on the connecting tube.It is most likely that the reported issue was the result of insufficient reprocessing and mishandling.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.

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 material in the air/water channel and on the distal end cover could not be identified and a definitive root cause of the issue could not be determined, however, due to the observed leak at the up/down angle knob, it is likely that device reprocessing could not be properly/efficiently completed.The event may be detected/prevented by following the instructions for use sections below: gif-h185 operation manual chapter 3 preparation and inspection.Gif-h185 reprocessing manual chapter 5 reprocessing the endoscope.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: 17812795
• MDR Text Key: 324224052
• Report Number: 9610595-2023-13988
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• 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: 09/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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