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)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the colonovideoscope exhibited the light guide and objective lenses adhesives had foreign material.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned and the evaluation found the light guide and objective lenses adhesives had foreign material.There was a cut on the switch 2 and wear on the grip o-ring causing water tightness to be lost.The air water cylinder had no color, the scope cylinder had no color, the forceps channel port had a scratch, the control unit is dirty due to water leakage, the scope identification failed as number of maximum cumulative uses was reached, the label on the scope connector is damaged, the charged coupled device unit is the position of the cable with limited length, the electrical connector is dirty due to water leakage, the scope connector has corrosion due to water leakage, the angle wire has a cut and cannot go in the up direction, the image guide protector has a chip, the light guide lens has a chip and the connecting tube has a wrinkle.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and 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 18 years since the subject device was manufactured.The legal manufacture was unable to confirm whether the customer's reprocessing steps were deviated from the instructions for use.  based on the results of the investigation, olympus confirmed foreign material came out of the device, but the type of the material cannot be identified.It is likely that the malfunction was due to improper reprocessing due to a leak in the switch two cutout, worn packing joint in the control section.Subsequently, the material could not be removed.Occurrence of the events can be detected/prevented by handling the device according to the following instructions for use (ifu).Detection methods are written in instructions for use (ifu): evis exera ii pcf type 180 series operation manual chapter 3 preparation and inspection.Prevention measures are written in instructions for use (ifu): evis exera ii 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: 18792997
• Report Number: 9610595-2024-04112
• Device Sequence Number: 7702355
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: PCF-Q180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2005
• 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