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

Model Number	CF-H180AI
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus, that the evis exera ii colonovideoscope had no lens washing.The issue occurred during a diagnostic colonoscopy and it was completed with the same device.Inspection and testing of the returned device found that the nozzle was clogged with foreign material resembling black rubber.There were no reports harm associated with the event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned for evaluation and the customers allegation was not confirmed.It was noted that the flexibility adjustment ring and grip had a scratch.The scope cover plate had peeling and the air/water cylinder and scope cylinder had no color.The indication on the switch 1 was unclear and the cover of the light guide bundle was damaged.The insulation resistance at the distal end did not meet standard value due to adhesive peeling on the bending section rubber.A foggy image occurred due to damage to the objective lens.The amount of water contact did not meet standard value due to nozzle clogging.The bending angle in the up direction did not meet standard value due to wear of the angle wire.The connecting tube coating was peeling and the universal cord had a wrinkle.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.The customer later provided there were no malfunction with reprocessing accessories.It is unknown/unanswered if there was a delay in precleaning.No delay in manual cleaning.It is unknown/not answered if air / water flush during pre-cleaning.Aniosime xl3 detergent was flushed during manual cleaning.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 foreign material was unable to be identified.The likely cause of the reported event is due to insufficient or inadequate reprocessing.However, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) section which state: -inspection of the endoscopic system.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 17442434
• Report Number: 9610595-2023-11010
• Device Sequence Number: 11441242
• Product Code: FDF
• UDI-Device Identifier: 04953170339592
• UDI-Public: 04953170339592
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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-H180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2011
• 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