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

Model Number CF-H260DL

Device Problems Device Handling Problem (3265); Failure to Clean Adequately (4048)

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

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record and historical complaint analysis was conducted, and no deviations that could have caused or contributed to the reported issue were identified.The device was returned to olympus for inspection, and the customer's complaint of erosion was identified as white contamination in the air and water channels.Based on the results of the investigation, remnants of white crystalized contamination believed to be a simethicone-type product was evident within the air and water channels.It was clear that the foreign material was a simethicone-type product; however, the material could not be specifically identified.The presence of this type of contamination highlights a potential root cause of customer handling and/or reprocessing issues.The event 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" and "ifu states that preventive measure in evis lucera gif/cf/pcf/sif type 260 series reprocessing manual chapter 3 cleaning, disinfection, and sterilization procedures." in addition, the following non-reportable malfunctions were found during the device evaluation: light cover glass adhesive, optical cover glass adhesive, distal end cap, and distal end adhesive were all found to be worn.The outlet pipe sealant was worn, the insertion tube protector was split, the identity badge was missing, the switch condition was worn and leaking, the pin unit was corroded, the biopsy channel was leaking, the angulation up/down/left and right was out of specification, the angle play up/down/left/right was evident, and the electrical safety test was out of specification.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, the evis lucera colonovideoscope had erosion at the distal tip.The issue was found during maintenance.There was no report of patient harm.During the device evaluation, it was found that there was contamination identified in the air / water channels.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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: 18361424
• MDR Text Key: 330956762
• Report Number: 9610595-2023-19934
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H260DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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