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
The device was returned to olympus for evaluation.The following findings from evaluation are the flexibility adjustment ring forceps channel port, right/left knob, upward/downward angulation control knob, switch box, universal cord, and grip had scratches.The air/water and suction cylinders had no color.Due to a pinhole on connecting tube, water tightness was lost.Endoscopic position detecting probe was damaged and the position detection function does not work.The plastic distal end cover/probe cover and the light guide lens had a chip.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The loaner device was sent with no complaint.During the device evaluation, the following reportable malfunctions were found: air/water tube and cylinder with foreign material.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.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 root cause of the event was unable to be identified.It was confirmed that there was a foreign object attached to/clogged in the air and water cylinder and air/water channels, but it was not possible to identify the foreign object.It is likely that reprocessing could not be performed and the foreign object could not be removed due to a leak failure at the insertion section.The detection method is described in the instruction manual evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Prevention measures are described in the instruction manual 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: 18177123
• Report Number: 9610595-2023-17747
• Device Sequence Number: 7625915
• Product Code: FDF
• UDI-Device Identifier: 04953170339653
• UDI-Public: 04953170339653
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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-H180DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2009
• 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