MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II COLONOVIDEOSCOPE

Model Number	PCF-Q180AL
Medical Device Problem Codes	Partial Blockage (1065); Device Reprocessing Problem (1091); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has been returned and evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.The definitive cause of the customer's experience cannot be determined at this time.Physical evaluation of the complaint device reveals: the device passed the leak test.The air/water supply had a clogged nozzle.The rgb dot had scattered image.The insertion tube was kinked/crimped.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported while preparing an evis exera ii colonovideoscope for use, black specs came out of the device when it was hooked up to a dryer.There was no patient contact/impact related to this occurrence.
Additional Manufacturer Narrative
This reported is being updated to provide investigation findings and additional information provided by the customer.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: ifu(reprocessing manual): to prevent clogging of the air/water nozzle, always use the aw channel cleaning adapter to clean the air/water channel after each use.Conclusion: the definitive cause of the user's experience could not be determined.Based on the available information the following are the presumed possible causes: physical evaluation of the complaint showed the clog in the nozzle to be rubber pieces.It is possible that silicone rubber products used in the endoscopy room and/or the injection tube and scope accessories, may have been mixed up inadvertently.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11174013
• Report Number: 8010047-2021-01405
• Device Sequence Number: 19524666
• Product Code: FDF
• UDI-Device Identifier: 04953170307720
• UDI-Public: 04953170307720
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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-Q180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1