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

Model Number	CF-H180AL
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus field service engineer (on behalf of the customer) reported to olympus that the colonovideoscope had angulation play and not enough and insertion tube discolored/stain/wrinkled.Customer found the problem in their reprocessing time.Needed detailed inspection of the subject device.There was no report of patient harm associated with the event.The device was returned for evaluation.During the device evaluation, found the scope had foreign objects in the following parts: the plastic distal end cover, bending section cover and in the connecting tube.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was evaluated and the customer's allegations were not confirmed.In addition to reportable finding mentioned in reportable event description, the device evaluation found following findings: due to damage on airwater-tube, water tightness was lost; due to damage on the charged coupled device unit, the image had shadows; the nozzle was shaved; the light guide lens had a chip; the plastic distal end cover had a dent; the adhesive on bending section cover was detached; the connecting tube had a wrinkle; due to wear of angle wire, bending angle in up/down/right direction did not meet the standard value and discoloration was found on the switch box and switch 1 and 2.Scratches were found on the objective lens and the universal cord; there was corrosion on the electrical connector and the light guide bundle had breakage.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, as well as additional information provided by the customer.Please see updates to b3, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, the foreign material could not be identified.Additionally, it¿s likely the foreign material was not removed because the reprocessing was not conducted properly due to leakage and breakage of the air/water channel.The final root cause of this event was unable to be identified.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: operation manual includes detection methods in chapter 3 preparation and inspection.Reprocessing manual includes preventive measures in chapter 5 reprocessing the endoscope (and related reprocessing accessories).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: 18206370
• Report Number: 9610595-2023-18019
• Device Sequence Number: 18009325
• Product Code: FDF
• UDI-Device Identifier: 04953170202445
• UDI-Public: 04953170202445
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2012
• 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