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

Model Number CF-HQ190L

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Event Description

Olympus was informed that during an onsite visit, the user facility staff was not performing aspiration during manual cleaning.The staff were not using the maj-855 to flush the auxiliary channel and the facility did not have a suction machine.No patient infections or injuries reported.

Manufacturer Narrative

Based on the observation summary report from an endoscopy support specialist (ess), there were some reprocessing deviations observed during the on-site visit, and they are as follows: the user facility staff was not performing aspiration during manual cleaning.Customer was not using the (maj-855) auxiliary water tubes to flush the auxiliary channel and the facility did not have a suction machine.The ess reviewed leak testing, manual cleaning and storage for this in-service and explained the process for aspirating detergent solution and using the maj-855 to flush the auxiliary channel.Staff understood the process.Notified the customer to purchase a suction machine, mh-856 suction cleaning adapters, and maj-855 auxiliary water tubes and additional units of mh-946 injection tubes, and mh-944 channel plugs.The ess provided a reprocessing in-service or reprocessing training to the user facility staff.The ess provided the user facility staff reprocessing training materials for their reference.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: d9 and e3.Additional information added to fields h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.The device was not returned to olympus for inspection, and the customer's allegation was not confirmed.Based on the results of the investigation, it is likely that there was a difference in recognition on device handling or reprocessing steps between olympus recommendation and the user.Olympus expert staff has already conducted training on proper reprocessing for the user.The event can be detected/prevented by following the instructions for use: preventive measure is described in ifu: gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 19098689
• MDR Text Key: 340711873
• Report Number: 9610595-2024-07782
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1