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

Model Number	CF-HQ1100DI
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This complaint is related to 9610595-2024-22151.
Event or Problem Description
The customer reported having used the colonovideoscope on six patients while awaiting the results for routine culture testing.Positive culture test results were subsequently received.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, the device evaluation and the lms final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.As a result of reviewing reprocessing steps provided by the user, no information to judge obvious deviation from ifu was obtained.The culture test result at the third-party labs provided by the user: sampling date: (b)(6) 2024.Sampling from: unknown.Cfu: ~2 cfu/endoscope.Bacterial identification: pseudomonas sp.The following are results of microbiological tests by the third-party labs, provided by service business center: sampling date: (b)(6) 2024.Sampling from: all channels.Cfu: <1 cfu/endoscope.Bacterial identification: n/a.No bacteria were detected in culture test performed by the third-party labs which result provided by service business center.The device was evaluated, and no abnormalities were found that could have led to the reported event.Based on the results of the investigation, the relevance between the device and the detection of bacteria could not be established and a root cause could not be determined.Ifu states ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ to warn about inappropriate reprocessing.Olympus will continue to monitor the field performance of 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: 20582983
• Report Number: 9610595-2024-22412
• Device Sequence Number: 15477622
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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?: Device Returned to Manufacturer
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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