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
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.In addition to nozzle is clogged by a black rubbery material, additional evaluation findings are as follows: lens glue plus charged coupled device cover lens glue deteriorated, bending section cover glue discolored, key top 1 was damaged, and angulations were out of specification.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.
Event or Problem Description
The customer reported to olympus that the colonovideoscope had no air/water flow.During the evaluation the following reportable malfunction was found: the nozzle is clogged by a black rubbery material.There was no report of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6, h11.Corrected fields: d5, e1, h4.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 and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and it was unknown if reprocessing was performed according to the instructions for use (ifu).Therefore, the cause of the material remaining in the device could not be determined.The event can be detected/prevented by following the instructions for use which state: 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: 18303841
• Report Number: 9610595-2023-19252
• Device Sequence Number: 6615420
• Product Code: FDF
• UDI-Device Identifier: 04953170339592
• UDI-Public: 04953170339592
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/29/2024

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: Other
• Device Model Number: CF-H180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2014
• 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