MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE COLONOVIDEOSCOPE

Model Number CF-HQ290L

Device Problems Contamination (1120); Device Handling Problem (3265)

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

Event Date 04/02/2023

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated and customer allegation ¿loose angulation knob¿ was confirmed.The device exhibited reduced angulation and the knob exhibited free play.There were few additional findings.Light guide cover lens and optical cover lens was chipped.The adhesive of the insertion section was worn out.The distal end cap and distal end adhesive was worn out.The insertion tube was stained and the insertion tube protector was split.The control body casing was stained.The aspiration housing of the colored ring was worn out.The angle control and break knob was stained.The device failed the electrical safety test.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.

Event Description

The customer reported to olympus that the angulation knob of the evis lucera elite colonovideoscope was loose.The issue was identified during an unknown procedure.The procedure was completed with the same device.There was no delay in the procedure.The subject device was returned and an evaluation at the repair center revealed a white contamination in the air/water channel which seemed to be simethicone type product.This report is being submitted to capture the reportable malfunction found during evaluation.There were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, and to correct information found in the initial report.The following section was corrected: h4.Based on the results of the legal manufacturer's investigation, the suggested event ¿white contamination in a/w channel¿ was confirmed, and the specifications and functions were not satisfied.The foreign material was found to be infacol (simethicone).It was likely that foreign material remained due to deviation from ifu in user handling.However, it was confirmed that by the reports: "962-0125, 962-0124, 063-1903, and 066-3255" that performance of reprocessing on the device is secured by reprocessing in accordance with ifu.(cleaning/ disinfection/ sterilization).There was no physical damage at the point where foreign material was detected.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.The suggested event is detectable and preventable by handling the device in accordance with the following ifu.Gif/cf/pcf-290 series operation manual includes the detection way in chapter 3 preparation and inspection.Gif/cf/pcf-290 series operation manual includes the preventive measures in 3.8 inspection of the endoscopic system: nothing other than sterile water should be used for air/water feeding.No additives should be put into the sterile water.Non-sterile water may cause patient cross-contamination and or infection.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 16755305
• MDR Text Key: 313445659
• Report Number: 9610595-2023-06249
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ290L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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