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

Model Number	CF-Q160S
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the complaint was confirmed and there was no air/water flow due to a clogged air/water channel and nozzle.Also, evaluation found leaks between the up/down and right/left knobs, the distal end plastic cover was dented, the bending section cover adhesive was cracked, the image was ok after a fog test, and switch #1 was cut.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported the evis exera sigmoidovideoscope had no air/water flow, a blocked air channel, and the nozzle was clogged.A blocked air channel error message was displayed on the medivator endoscope reprocessor every time the customer tried to reprocess the scope.There were no reports of patient harm.
Additional Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over five (5) years since the subject device was manufactured.Based on the results of the investigation, the root cause could not be determined, however it is likely the following led to the malfunction: the foreign material could not have been removed because reprocessing could not be conducted properly due to leakage from upward/downward angulation control knob and right/left angulation control knob.The event can be prevented by following the instructions for use which state: ifu states the detection method in cf-q160s operation manual chapter 3 preparation and inspection.Ifu states the preventative measures in cf-q160s reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.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 (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: 18138731
• Report Number: 9610595-2023-17244
• Device Sequence Number: 15093154
• Product Code: FDF
• UDI-Device Identifier: 04953170067310
• UDI-Public: 04953170067310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: CF-Q160S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2018
• 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