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

Model Number	CF-HQ190L
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The olympus endoscopy support specialist (ess) performed a reprocessing in-service/customer competency.The ess noted the facility utilized the medivator¿s scope buddy plus for manual cleaning and manual flushing of endoscope channels.For manual high-level disinfection, rinsing, and alcohol flush, the facility used medivator¿s reprocessor.All olympus recommended reprocessing guideline steps were reviewed following the olympus reprocessing manuals during the in-service.The device was returned to olympus for evaluation and the reported issue was not confirmed.Multiple leaks were found in the biopsy channel and scope connector/plug unit.There was a scrape mark in the biopsy channel.Switch one (1) had a pinhole.The distal end plastic cover had dents.The bending section cover glue was cracked.The control knob movement had play.The insertion tube had minor peeling.The control body and the customer label on the grip had minor scratches.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported by the customer, the end user was using simethicone infused water for precleaning of the evis exera iii colonovideoscope.Additionally, the staff was not knowledgeable of the delayed reprocessing time and the staff was not completing all the steps of manual cleaning per the instructions for use.A total of six (6) evis exera iii colonovideoscopes were affected.The facility leadership was concerned that the residual of simethicone may be in the endoscope channels.A concern for the harboring of bioburden and biofilm was a risk.The issue was found during maintenance.No patient harm reported.This complaint is related to patient identifiers; (b)(6).
Additional Manufacturer Narrative
The olympus endoscopy support specialist (ess) performed a reprocessing in-service/customer competency.The ess noted the facility utilized the medivator¿s scope buddy plus for manual cleaning and manual flushing of endoscope channels.For manual high-level disinfection, rinsing, and alcohol flush, the facility used medivator¿s reprocessor.All olympus recommended reprocessing guideline steps were reviewed following the olympus reprocessing manuals during the in-service.The device was returned to olympus for evaluation and the reported issue was not confirmed.Multiple leaks were found in the biopsy channel and scope connector/plug unit.There was a scrape mark in the biopsy channel.Switch one (1) had a pinhole.The distal end plastic cover had dents.The bending section cover glue was cracked.The control knob movement had play.The insertion tube had minor peeling.The control body and the customer label on the grip had minor scratches.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported by the customer, the end user was using simethicone infused water for precleaning of the evis exera iii colonovideoscope.Additionally, the staff was not knowledgeable of the delayed reprocessing time and the staff was not completing all the steps of manual cleaning per the instructions for use.A total of six (6) evis exera iii colonovideoscopes were affected.The facility leadership was concerned that the residual of simethicone may be in the endoscope channels.A concern for the harboring of bioburden and biofilm was a risk.The issue was found during maintenance.No patient harm reported.This complaint is related to patient identifiers; (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the reporter.See updated section b5.
Event or Problem Description
Additional information was received from the reporter.There was an ongoing investigation about the reprocessing of the endoscopes at the facility.The facility was sending all scopes for evaluation and patients were being notified to come in and get a blood test.No patient information available at this time.Additional information was received from the customer at a later time stating there was no death or injury or infection that occurred during the event.This complaint is related to patient identifiers; (b)(6).
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, and considering the following observations, it is likely the event occurred because the facility staff was inadequately trained in reprocessing and/or device handling in accordance with the instructions for use (ifu): the end user was using simethicone infused water for precleaning of the endoscopes.Staff was not knowledgeable of the delayed reprocessing time.Staff was not completing all steps of manual cleaning per the ifu.He user had concern about risk from the above deviations and sent the device to olympus.The event can be detected/prevented by following the instructions for use which state: 1.4 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.¿ ¿some national or professional guidelines recommend using a detergent solution for precleaning.Consult with your hospital¿s infection control committee regarding use of the detergent solution.Do not apply lubricants to the aw channel cleaning adapter.Lubricants may cause malfunction of the aw channel cleaning adapter.¿ ¿if the endoscope and accessories used in the patient procedure are not immediately cleaned after each patient procedure, residual organic debris will begin to dry and solidify, hindering effective removal and reprocessing efficacy.Preclean the endoscope and the accessories at the bedside in the patient procedure room immediately after each patient procedure.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13591003
• Report Number: 8010047-2022-03493
• Device Sequence Number: 4499020
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2022

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-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/01/2022; 04/06/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/24/2022; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2019
• 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