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)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the evis exera ii colonovideoscope had a poor light output.The device was returned to olympus for evaluation.During evaluation, foreign material was found in the auxiliary channel.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation (foreign material).Additional details have been requested regarding the reported issue.At this time no additional information has been provided.No adverse effects to patient were reported.
Additional Manufacturer Narrative
The foreign material that came out of the auxiliary water channel was suspected to be a result of insufficient cleaning of the device.During testing, the reported issue was confirmed; the device had uneven illumination due to breakage of the light guide bundle.During visual examination, other issues were found: the flexibility adjustment ring was scratched; the grip was scratched; the air/water cylinder was missing the color indicator; the scope cylinder was missing the color indicator; the switch box was scratched; the the light cover glass was damaged; the light cover rod was damaged; the objective lens was scratched; the light guide lens was stained; the bending section cover adhesive was discolored; and the connecting tube was wrinkled.Functional testing showed the distal end's insulation resistance did not meet with specifications due to a burn on the connector cover.Both directional knobs had excess play due to a worn angle wire.Finally, examination of the device data showed the total allowed cumulative uses had been reached.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was confirmed - however, the foreign material in the auxiliary water channel was unable to be further specified.Moreover, no deformation of the channel was observed, nor was any obvious deviation of reprocessing.Therefore, the cause of the remaining foreign material could not be presumed from the obtained information.The event can be detected and prevented in accordance with the following instructions for use (ifu): the instruction manual evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection describes how to detect for the suggested event.The instruction manual evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) describes how to prevent for the suggested 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: 17670277
• Report Number: 9610595-2023-12613
• Device Sequence Number: 7067913
• Product Code: FDF
• UDI-Device Identifier: 04953170339592
• UDI-Public: 04953170339592
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 08/13/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2014
• 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