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

Model Number	CF-H180DL
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the evis exera ii colonovideoscope no air/ water flow, lens water rinsing doesn't work.Fault with butter in the connector (connection unit) during maintenance.During inspection and evaluation, whitish foreign material was found inside the auxiliary channel.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the customer's allegation was confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: - due to damage on flexibility adjustment ring, flexibility adjustment function does not work, air/water cylinder has discoloration, suction cylinder has discoloration, scope cover plate has peeling, due to clogging of nozzle, no water is fed, due to wear of angle wire, bending angle in up direction does not meet specifications, plastic distal end cover has a crack, light guide lens has a chip, adhesive on bending rubber has a crack, and universal cord has coating peeling.The investigation is on-going.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 answered the following questions: was the device reprocessed before the device was sent in to the repair center? yes delay of pre cleaning? no delay of manual cleaning (if delayed, pre soaking is required)? no flushing water during pre cleaning? yes flushing detergent during manual cleaning? no, the detergent is only used on washing machine.The blow did not work with carbon dioxide, with air it worked better.Scope was washed and prewashed normally after every endoscopy.Scope was washed before sending it to repair.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, it is likely that the foreign material remained due to insufficient cleaning.However, the definitive root cause was unable to be determined.The foreign material was unable to be identified.The event can be prevented by following the instructions for use: "instruction manual evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection shows how to detect the event.Instruction manual evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) shows how to prevent the event." 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: 17148130
• Report Number: 9610595-2023-08963
• Device Sequence Number: 5744571
• Product Code: FDF
• UDI-Device Identifier: 04953170339653
• UDI-Public: 04953170339653
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K051645
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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-H180DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2009
• 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