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

Model Number	PCF-HQ190I
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and in addition to the reported in b5, the evaluation found the following: the insulation resistance is out of specification due to burn on plastic distal end cover (c-cover), the air/water (aw) cylinder and the suction cylinder (s-cylinder) had no color, the switch box and the plug unit had a scratch.The label on scope connector (s-connector) was peeled, due to wear of the angle wire the bending angle in the up direction did not meet the standard value, and the plastic distal end cover (c-cover) had a crack.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was observed that during the device evaluation, the colonovideoscope exhibited the air/water (aw) tube, aw cylinder, and the jet tube (j-tube) had foreign objects.There was no patient involvement.
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 foreign (white) material was unable to be identified any further.Although, there was no physical damage on the areas where the foreign material remained.Deviations from instruction for use (ifu) are unknown.The root cause of the reported event is unable to be conclusively determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.The event can be detected and prevented by following the instructions for use (ifu) sections: ifu states that detection method in gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 18629721
• Report Number: 9610595-2024-02286
• Device Sequence Number: 20815762
• Product Code: FDF
• UDI-Device Identifier: 04953170416132
• UDI-Public: 04953170416132
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192793
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: PCF-HQ190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2024
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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