MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. RE EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260

Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

It was observed that during the device evaluation, the gastrointestinal videoscope exhibited foreign objects from the nozzle and plastic distal end cover.There were no reports of patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and it was unknown if reprocessing was performed according to the instructions for use (ifu).Therefore, the cause of the material remaining in the device could not be determined.The events can be detected and prevented in accordance with the following ifu.Ifu states that detection method in evis lucera gif/cf/pcf type 260 series operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in evis lucera gif/cf/pcf/sif type 260 series reprocessing manual chapter 3 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: RE EVIS LUCERA 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: 18926787
• MDR Text Key: 337950080
• Report Number: 9610595-2024-05746
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/19/2024

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: Other
• Device Model Number: GIF-Q260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2009
• 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