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

Model Number	CF-Q160S
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the distal end cover had chips and deep scratches, the objective lens was chipped, the air/water flow was weak, the nozzle was clogged, the insertion tube had minor scratches, and the light guide tube had minor scratches.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 sigmoidovideoscope had issues with the air flow.Inspection and testing of the returned device found that the nozzle was clogged.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 could not be determined.It was confirmed that the air water nozzle was clogged with foreign material, however, the specific material could not be identified and the cause for the clog could not be specified.The nozzle was not reported to have been deformed or damaged.Attempts were made to obtain additional information regarding the user's reprocessing and handling steps but no information was available.The event can be detected and prevented by following the instructions for use (ifu) which state: "operation manual_ preparation and inspection.Inspection of the endoscope.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.Inspection of the endoscopic system.Inspection of the air-feeding function.Inspection of the objective lens cleaning function.Regarding reprocessing of a/w nozzle/channel, ifu states as follows: reprocessing manual_ precleaning the endoscope and accessories warning: if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Flush the air/water channel with water and air_ caution:to prevent clogging of the air/water nozzle, always use the aw channel cleaning adapter to clean the air/water channel after each use.Manual cleaning_ cleaning, disinfection and sterilization procedures.Flushing detergent solution into the air/water channels.Flush the air/water channel with detergent solution.Removing detergent solution from all channels.Presoak for excessive bleeding and/or delayed reprocessing after each procedure follow the steps below only in cases of excessive bleeding and/or delayed reprocessing; unnecessary immersions should be avoided.Consecutive extended immersions may damage the endoscope." in addition, the following non-reportable malfunction was found during the device evaluation, universal cord was scratched.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA SIGMOIDOVIDEOSCOPE
• Common Device Name: SIGMOIDOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15481478
• Report Number: 9610595-2022-02234
• Device Sequence Number: 6744442
• Product Code: FDF
• UDI-Device Identifier: 04953170067310
• UDI-Public: 04953170067310
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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-Q160S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2006
• 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