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

Model Number GIF-HQ190

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The asset device was returned to olympus.Upon inspection and testing of the returned device, the follow defects were found, switch box discolored, air/water-cylinder had no color, suction cylinder has no color, grip scratched, plug unit scratched, due to wear of angle wire, the play of up/down knob out of the standard value, distal end cover cracked, adhesive on angle rubber cracked, connecting tube scratched, and universal cord scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A user facility returned the olympus asset, evis exera iii gastrointestinal videoscope, to the olympus service center.Upon inspection and testing of the returned device, whitish foreign material was found in the scope air/water tube and air/water cylinder due to insufficient cleaning.This report is being submitted for the event found during evaluation.There was no patient involvement, no harm or user injury reported due to the event.

Manufacturer Narrative

This report has been submitted to provide correction to g3 on the initial medwatch # 177713 (report id: 9610595-2023-12590) submitted on aug 31, 2023 and the correct g3 (date received by manufacturer) is aug 18 2023.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or 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 foreign material could not be identified nor the root cause of it.The event can be detected/prevented in accordance with the following instructions for use: the instruction manual gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection describes how to detect for the suggested event.The instruction manual gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope describes how to prevent for the suggested event.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: 17666939
• MDR Text Key: 322495093
• Report Number: 9610595-2023-12590
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 11/07/2023
• Supplement Dates FDA Received: 08/31/2023; 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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