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

Model Number GIF-Q260J

Device Problems Defective Component (2292); Failure to Clean Adequately (4048)

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

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and in addition to the phenomena identified in b5, the evaluation also found that the foreign material was rubber gloves stuck in the instrument channel, the bending angle in the up direction did not meet standard value due to stretched angle wires, and the plastic distal end cover was slightly worn.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the gastrointestinal videoscope had foreign material in the channel tube and the tip was defective.The issue was found during a therapeutic procedure.The device was reprocessed, and the procedure was completed using the same device.There were no reports of delays or patient harm.The device was returned to service where evaluation found rubber gloves in the instrument channel tube.This report is being submitted for the reportable malfunction found at evaluation.

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.The device was visually inspected, and functional testing was performed.The device did not meet the standard specifications.Based on functional testing, the adhesion/clogging of the material in the biopsy channel was confirmed.It could not be specified what the foreign material was nor the root cause of the remaining foreign material.It was unknown if the reprocessing steps were implemented in line with the instructions for use (ifu).Performance of reprocessing on the device was secured in the reports by reprocessing appropriately in accordance with instructions for use (ifu/cleaning/disinfection/sterilization).It was confirmed that the section of the device with the foreign material residue had no deformation.There was no report that the device was used for procedure while the event occurred.The suggested events can be detected and prevented by handling the device in accordance with the following instructions for use (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.A definitive root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18493424
• MDR Text Key: 332735160
• Report Number: 9610595-2024-00710
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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