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

Model Number	PCF-Q180AI
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 and the evaluation found the connecting tube had a cut and the auxiliary water inlet was deformed.Due to deformation of electrical connector guide pin, the water tightness was lost.Due to burn on plastic distal end cover, the insulation resistance value at distal end does not meet the standard value.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device evaluation, the colonovideoscope exhibited foreign material in the air/water tube, air/water cylinder, jet-tube and connecting tube.In addition, the adhesive on the bending section cover had foreign material attached in the edges.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h6.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 subject device was manufactured.Based on the results of the investigation, foreign material was detected in the air/water cylinder, air/water channel, auxiliary water channel, edge of bending section cover, and in the gap of scratch at the insertion section.The cause of the foreign material could not be determined.The materials may not have been removed because reprocessing could not be conducted properly due to the leakage from a deformed electrical connector guide pin.The event can be detected and prevented by following the instructions for use: detection methods are written in ifu: evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Prevention measures are written in ifu: 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: 18744409
• Report Number: 9610595-2024-03574
• Device Sequence Number: 17741539
• Product Code: FDF
• UDI-Device Identifier: 04953170339172
• UDI-Public: 04953170339172
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: PCF-Q180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2012
• 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