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

Model Number	CF-HQ1100DI
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the colonovideoscope asset check failed requiring repair.The issue occurred during preventive maintenance.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr).Further review found there was no reportable malfunction related to the subject device captured in this complaint.The initial mdr was inadvertently submitted as a reportable malfunction.The initial medwatch reported that the device failed asset check during repair.This event was an asset return and there was no device defect.This is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 20687959
• Report Number: 9610595-2024-23452
• Device Sequence Number: 18002294
• Product Code: FDF
• UDI-Device Identifier: 04953170424298
• UDI-Public: 04953170424298
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K222584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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-HQ1100DI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown