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

Model Number	PCF-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
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found that there was foreign material in the air/water tube, the air/water cylinder and in the auxiliary jet channel.The reportable malfunction was likely a result of insufficient reprocessing.The evaluation found the air/water cylinder, and the suction cylinder had no color.The grip, the universal cord, and the charged coupled device cable, all had a scratch.The water tightness was lost due to deformation of electrical connector guide pin, the insulation resistance value at distal end did not meet the standard value due to a chip on probe cover, the bending angle in up direction exceeded the standard value due to deformation of the bending tube, the light guide lens has a crack, the adhesive on distal sheath had white-clouded area, a noise image occurred during angulation in up/down directions due to damage on charged coupled device unit.The investigation is ongoing and follow up with the user facility is currently being performed.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
The customer reported to olympus, the colonovideoscope had an angulation malfunction.The device was returned for evaluation.During the device evaluation, there was a foreign material in the air/water tube, the air/water cylinder and in the auxiliary jet channel.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the event, ¿foreign material in the a/w cylinder, a/w channel¿, was confirmed.The white material inside channel was likely simethicone used during procedure.The root cause of the remaining foreign material could not be identified.The foreign material was possibly not removed since the reprocessing was not conducted properly due to leakage due to deformation of el-connector guide pin.There was no report that the device was used for procedure while the event occurred.Performance of reprocessing on the device was secured in the reports by reprocessing appropriately in accordance with instructions for use (ifu/cleaning/disinfection/sterilization).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 device was manufactured.The suggested events can be detected and prevented by handling the device in accordance with the following instructions for use (ifu): ¿ ifu states that detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.¿ ifu states that preventive measure 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: 18509615
• Report Number: 9610595-2024-00872
• Device Sequence Number: 7875743
• Product Code: FDF
• UDI-Device Identifier: 04953170339882
• UDI-Public: 04953170339882
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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-H180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/14/2024
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2012
• 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