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

Model Number	PCF-H180AL
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 and the evaluation found the following: suction cylinder has discoloration; scope cover has a scratch; forceps channel port has a scratch; due to burn on distal end over, insulation resistance value at distal end does not meet the standard value; due to wear of angle wire, the play of up/down knob is out of the standard value; due to wear of angle wire, the play of right/left knob is out of the standard value; light guide lens has a crack; and the universal cord has a dent.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus the evis exera ii colonovideoscope, had loose tie rods.The issue occurred during an unknown event.The procedure was unknown.There were no reports of patient or user harm associated with this event.The device was returned to olympus for evaluation, and the evaluation found that the jet tube had a foreign material.This report is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
H10: per additional information from the customer, the reprocessing steps at the material residue point did not deviate from the instruction manual.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 12 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of foreign material in the auxiliary water channel could not be identified.The suggested event is detectable and preventable by handling the device in accordance with the following sections of the instructions for use: - the instruction manual evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection describes how to detect for the suggested event.- the instruction manual evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) describes how to prevent the suggested event.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: 17950905
• Report Number: 9610595-2023-15314
• Device Sequence Number: 20750555
• Product Code: FDF
• UDI-Device Identifier: 04953170237287
• UDI-Public: 04953170237287
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: PCF-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2010
• 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