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

Model Number PCF-H190DL

Device Problems Partial Blockage (1065); Particulates (1451)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, the customer's issue was confirmed to be foreign material which was lodged in the device's nozzle specifically.The customer's originally reported issue was therefore confirmed.The following additional findings were also noted: switch(evis)/camera-cut/hole on sw 1.Forceps passage-non biohazard material in channel.D/e plastic cover-deep dents.Ob lens-worn glue.Lg lens-edge chip/worn glue.A rubber glue crack.Suction flow-foreign material.The investigation is ongoing, and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.

Event Description

It was reported by the customer that there was foreign material lodged in their evis exera iii colonovideoscope device.The customer was unable to remove the material despite numerous attempts to clean it.The reported issue was discovered during the reprocessing of the device.There were no reports of patient or user harm associated with this event.

Event Description

Additional event information received from the customer: the cause of the foreign material was someone was training and instead of sucking up water they accidently sucked up the solidifier.We were able to reprocess the scope successfully, but the solidifier wouldn¿t budge from the inside.

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 reported foreign material in the channel was identified as solidifier.The root cause of the issue was reported as a user mistake during reprocessing training.The event may be detected/prevented by following the instructions for use which state: ¿inspection of the instrument channel¿.¿avoid aspirating solid matter or thick fluids; instrument channel, suction channel, or suction valve clogging can occur.If the suction valve clogs and suction cannot be stopped, disconnect the suction tube from the suction connector on the endoscope connector.Turn the suction pump off, detach the suction valve, and remove solid matter or thick fluids.¿.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: 16359560
• MDR Text Key: 309907559
• Report Number: 9610595-2023-02306
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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