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

Model Number CF-EZ1500DL

Device Problems Image Display Error/Artifact (1304); Failure to Clean Adequately (4048)

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

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

During testing, the reported issue was confirmed: the image did not meet with specifications for resolution, zoom function or dual focus.In addition, the device failed leak testing due to damage at the bending section cover.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported to olympus that the colonovideoscope had image failure in several x1 towers.The device was returned to olympus for evaluation.During evaluation, foreign material was found in the air/water cylinder.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No adverse effects to patient reported.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The issue occurred during the middle of a therapeutic equipment test causing a 2 hour delay while the patient was under deep sedation.The intended procedure was competed with another device.There was no death injury or infection to a patient or healthcare professional.No other devices were involved in the event.

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.It has been about 3 years since the subject device was manufactured.Based on the results of the investigation, the reported two-hour procedural delay was due to a defect with the charge-coupled device (ccd-unit).There was leakage from the bending section cover (a-rubber).This caused an abnormality of the circuit board due to water invasion (such as short circuit) which led to the reported issue.However, the root cause could not be determined.Regarding the foreign material adhering to the air/water cylinder, although olympus confirmed the issue, the specific foreign material could not be identified.Therefore, the root cause could also not be determined.The event can be detected/prevented by following the instructions for use (ifu) in sections: ¿operation manual: inspection of the endoscopic system inspection of the endoscopic image.¿ ¿operation manual: section 3.3 inspection of the endoscope - detection section 3.8 inspection of the endoscopic system ¿ detection.¿ ¿reprocessing manual: section 5.5 manually cleaning the endoscope and accessories ¿ preventative measures.¿ olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18285438
• MDR Text Key: 330823575
• Report Number: 9610595-2023-19021
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-EZ1500DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• 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: 02/17/2021
• 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
• Patient Outcome(s): Other