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

Model Number	PCF-Q180AI
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 evis exera ii colonovideoscope that the bowden cable required adjustment.The device was returned to olympus for evaluation.During evaluation, foreign material was found in the auxiliary tube.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No adverse effects to patient reported.
Additional Manufacturer Narrative
During functional testing, the reported issue was confirmed; the angle wire was worn; this caused the bending angle to not meet specifications for the up direction.Functional testing also showed water could not be fully removed from the device due to peeling adhesive at the objective lens.Due to a crack on a-rubber, insulation resistance value at distal end does not meet the standard value.Visual examination found the following additional issues: the indicator marking on the grip was unclear; the air/water cylinder and scope cylinders were missing their color indicators; the objective lens was cracked; the light guide lens was cracked; and the universal cord was wrinkled.Examination showed the following components had scratches: flexibility adjustment ring; scope cover; switch box; and both directional knobs.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.Based on the results of the investigation, the observed foreign material in sub-water supply channel could not be identified and a definitive root cause of the issue could not be determined, as, there was no observe device deformation that might result in the retention of foreign material and it is unknown if the facility device reprocessing was implemented in accordance to the ifu, however, the issue was likely the result of insufficient device cleaning/reprocessing.The event may be detected/prevented by following the instructions for use sections below: evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.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: 17778126
• Report Number: 9610595-2023-13653
• Device Sequence Number: 17786146
• Product Code: FDF
• UDI-Device Identifier: 04953170339172
• UDI-Public: 04953170339172
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: PCF-Q180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2007
• 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