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

Model Number	CF-H180DL
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 returned the evis exera ii colonovideoscope with no information.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found there was a white crystalized foreign material resembling traces from a dry solution in the air/water tube and cylinder.The report is being submitted due to foreign material in the scope found during evaluation.
Additional Manufacturer Narrative
Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found that water tightness was lost due to wear of the scope cover packing, the forceps channel port was shaved, the scope cover was chipped, the air/water and suction cylinders had no color, the control unit was cracked, the mouthpiece was corroded, the electrical connector was corroded, illumination was uneven due to shaved adhesive around the light guide lens, the image had a partially dark area due to a chip on the objective lens, the light guide bundle was broken, the light guide lens was cracked, the bending section cover adhesive was cracked, the connecting tube was buckled, the coating of the universal cord was peeled, and multiple parts of the scope were scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
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 13 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 clogged in the air/water cylinder and air/water channel could not be further identified.The foreign material may not have been removed because reprocessing could not be conducted properly due to a leakage from the cover packing (labeled as the "s-cover").A further cause of the leakage could not be presumed.The suggested events are detectable/preventable by handling the device in accordance with the following instructions for use (ifu): ifu states the detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Ifu states the preventative measures in evis exera ii gif/cf/pcf type 180 series reprocessing manual 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: 17718659
• Report Number: 9610595-2023-13051
• Device Sequence Number: 7073431
• Product Code: FDF
• UDI-Device Identifier: 04953170339653
• UDI-Public: 04953170339653
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: 09/22/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2010
• 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