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

Model Number	CF-LV1I
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported to olympus, the colonovideoscope had air/water flow problem.The event occurred during preparation for use, prior to an enteroscopy procedure.It was reported that the procedure was completed using similar device with no delayed.Upon inspection and testing of the customer returned device, fibrous foreign material was found clogged in the scope nozzle due to insufficient or incorrect reprocessing.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.
Additional Manufacturer Narrative
The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, angles insufficient due to angle wires stretched, and foreign material clogged in scope nozzle.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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, the type and cause of the foreign material could not be identified.It is likely that the material was not completely removed even though the user reprocessed the device in accordance with instructions for use (ifu).The specific root cause could not be determined at this time.The user may detect the event properly by handling device in accordance with the ifu: ¿preparation and inspection.Inspection of the endoscope.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.Inspection of the endoscopic system.Inspection of the air-feeding function.Inspection of the objective lens cleaning function".The following information is stated regarding reprocessing in the ifu: "flush the air/water channel with water and air.Caution: to prevent clogging of the air/water nozzle, always use the aw channel cleaning adapter to clean the air/water channel after each use.Manually disinfecting the endoscope and accessories.Clean the external surfaces.Immerse the endoscope in the detergent solution.Thoroughly brush or wipe all external surfaces of the endoscope, using a clean lint-free cloth, brush, or sponge.Pay particular attention to the air/water nozzle opening and the objective lens on the distal end of the insertion section, and confirm that all debris is removed from all surfaces of the distal end.Flushing detergent solution into the air/water channels¿.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15053481
• Report Number: 9610595-2022-00091
• Device Sequence Number: 4773219
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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: 06/29/2022
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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
• Patient Sex: Unknown