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
Additional Manufacturer Narrative
In addition to the foreign material found in the air/water cylinder and tube, the following issues were identified: the air/water cylinder color ring was missing; the scope cylinder color ring was missing; the hand grip was sheared; the forceps channel was dented; the switch box was scratched; the guide pin of the electrical connector was deformed; the scope connector label was damaged; the electrical connector was discolored due to water leakage; the light guide bundle showed breakage; and the universal cord was wrinkled and scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer returned the evis exera ii colonovideoscope to olympus for routine maintenance.During evaluation, foreign material was found at the air/water tube and air/water cylinder.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No patient involvement reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to include the udi number that was inadvertently left off the initial mdr (see d4).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 14 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.The event can be detected/prevented by handling the device in accordance with the following section of the instructions for use: -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 operation manual chapter 3 cleaning, disinfection and sterilization procedures.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: 17712399
• Report Number: 9610595-2023-12973
• Device Sequence Number: 2149189
• Product Code: FDF
• UDI-Device Identifier: 04953170339653
• UDI-Public: 04953170339653
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 10/05/2023

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: 08/22/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 09/27/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/08/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2009
• 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