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

Model Number	CF-LV1I
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the returned device could not confirm the customer allegation.There were few additional findings.The insertion section was wrinkled.The bending cover was leaking.The channel port and suction port was worn out.The coating of the light guide tube was peeling off and was worn out.Objective lens was scratched.Switch was worn out.The universal cord had a wrinkle.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental will be submitted in completion of investigation or if any additional information is available.
Event or Problem Description
The customer reported to olympus, the colonovideoscope exhibited air/water feeding problem.The issue was found during an enteroscopy procedure.The patient was not under sedation.The procedure was completed with the same device.The device was returned and an evaluation revealed, the distal end of the device was dirty.This report is being submitted to capture the reportable malfunction found during evaluation.There were no reports of patient harm or injury associated with the event.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.
Event or Problem Description
It was further reported, the hospital did colonoscopic exam.
Additional 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.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was confirmed - however, the material observed on the distal end of the device could not be further identified.There was no information that suggested any obvious misuse of the device - therefore, a further cause of the suggested phenomenon could not be presumed.Olympus will continue to monitor field performance for this device.

• Brand Name: COLONOVIDEOSCOPE
• Common Device Name: 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: 16003193
• Report Number: 9610595-2022-05661
• Device Sequence Number: 17827118
• Product Code: FDF
• UDI-Device Identifier: 04953170312410
• UDI-Public: 04953170312410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CF-LV1I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/21/2022; 02/17/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 12/21/2022; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CV-V1 VIDEO SYSTEM CENTER
• Patient Sex: Unknown