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

Model Number CF-H260AI

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that the colonovideoscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

The issue was not confirmed, as the scope was not microbiologically tested by olympus.The investigation is ongoing and follow up with the customer is currently being performed.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer completed cleaning disinfection and sterilization (cds) checklist, the device evaluation and the lms final investigation.Despite good faith attempts the user culture results were not shared.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.The device was evaluated where no abnormalities were found that could have led to the positive culture.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, a root cause could not be determined.The reported event was not confirmed as the scope was not microbiologically tested by olympus.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19006327
• MDR Text Key: 339047637
• Report Number: 9610595-2024-06697
• Device Sequence Number: 1
• Product Code: FDF
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H260AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2015
• 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
• Treatment: EVIC LUCERA ELITE VIDEO SYSTEM CENTER.