MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problems Device Reprocessing Problem (1091); Device Contamination with Body Fluid (2317)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for this event as yet.Event date is not known.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, after reprocessing of the device, when the device was hung in the scope cabinet, the device leaked bloody water from somewhere in the tip.The tip was disinfected and the device boxed up.The device had passed the manual leak test.Every channel had been sponged down; the device was run on the endo flush with the proper adapter and in the medivator.There was no patient involvement.

Manufacturer Narrative

Relevant additional information has been received for this event.This information is being provided in this supplemental report.Please see the updates in sections: e2, e3, g4, g7, h2, and h10.The initial reporter is an endoscopy charge nurse.No patients were infected by the issue of reprocessing.They do use balloons with the scopes.The device was not used on any patient once the issue of the colored fluid was observed.The device was rerun and sent for repair.

Manufacturer Narrative

The device has been returned but an actual device evaluation not completed for it as it was considered a biohazard.Evaluation is performed by historical records and communication.This supplemental report is being submitted to provide this information.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.Customer communication reported that bloody water was leaking from the device from around the lens after reprocessing.Customer reported balloons are used in the procedure and there was no infection to any patient.Likely cause of the leaking bloody water is the foreign body had been lodged in the insufflated ch and that the fluid flowing back into the insufflation channel could not be removed during irrigation at the time of reprocessing, so the fluid flowed out from the insufflation channel.Scenario is as below: blood fluid refluxed into the scope tract during the case.Blood fluid retrograde into the tract coagulated and packed.Blood fluid coagulated and packed ducts could not be cleaned in the cleaning and disinfection process.Although the blockage in the conduit was not cleaned, bubbles and water flow from the tip could be checked during the pre-use inspection (bubbles may be released in the first few seconds even if water was delivered).Fluid in the tract was discharged as a foreign body from the nozzle.The instructions for use includes guidance on cleaning, disinfection, and sterilization procedures and precleaning (chapter 7) and preparation and inspection (chapter 3).

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10186746
• MDR Text Key: 197380942
• Report Number: 8010047-2020-03580
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170341793
• UDI-Public: 04953170341793
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1