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

Model Number	CF-HQ190I
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, in addition to the reported in b5, the device evaluation found the following: due to damage on the endoscopic position detecting unit, the endoscopic position detecting unit function does not work, due to wear of angle wire, the play of right/left knob is out of the standard value, jet tube has foreign objects, image guide protector is damaged, plastic distal end cover has a crack, objective lens has a scratch, bending section cover adhesive has wear.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported to olympus, the colonovideoscope is fragile, the bonds begin to break.There were no reports of patient or user harm associated with this event.The device was returned for evaluation.During the device evaluation, the jet tube was found to have white foreign material.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.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 5 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: 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: 18245257
• Report Number: 9610595-2023-18495
• Device Sequence Number: 15218767
• Product Code: FDF
• UDI-Device Identifier: 04953170416132
• UDI-Public: 04953170416132
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131780
• 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): 03/07/2024

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: CF-HQ190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• 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: 11/18/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2018
• 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