MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoscopy support specialist (ess) covered and explained the pre-cleaning, process following olympus guideline on reprocessing with the customer.Additionally, the pre-cleaning portion of the in-service included how to use the air water channel cleaning adapter and flushing the auxiliary water channel.The customer stated the adapter was not being used at pre-cleaning and was not flushing the auxiliary water channel at pre-cleaning.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
During an in-service in reprocessing of evis exera sigmoidovideoscope, the endoscopy support specialist (ess) observed a deviation in the scope cleaning process as the facility was not using the air water channel cleaning adapter and was not flushing the auxiliary water channel at pre-cleaning.The adapter is available but was not using it.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.The device history record for the subject device was reviewed and it was verified that the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation attributed the likely cause to insufficient training as stated on the ifu (instruction for use) as a preventive measure, the user manual states: ifu(reprocessing manual) cautions the customer against insufficient reprocessing as follows; precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.Ifu(reprocessing manual) provides the detailed usage of aw channel cleaning adapter in 2.8 aw channel cleaning adapter (mh-948).

• Brand Name: EVIS EXERA SIGMOIDOVIDEOSCOPE
• Common Device Name: SIGMOIDOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12028833
• Report Number: 8010047-2021-07716
• Device Sequence Number: 11578212
• Product Code: FDF
• UDI-Device Identifier: 04953170067310
• UDI-Public: 04953170067310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: CF-Q160S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1