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

Model Number GF-UCT260

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that the endoscopic ultrasonography, the subject device could not feed air.The user replaced the subject device with another device to complete the procedure.After the procedure, the user checked the subject device and blood came out from the air/water nozzle of the subject device.The user did not inspect the subject device for use of the subject device.The subject device reprocessed with an olympus automated endoscope reprocessor model oer-4 (not available in the usa) using peracetic acid and the user checked the subject device and there was no abnormality of the subject device.The user is using the subject device.Before this procedure, the procedure was an endoscopic ultrasound-fine needle aspiration, and the cancer test result of the patient was negative, and there is no suspicion of infectious disease.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

The subject device has not been returned to olympus for evaluation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation, the legal manufacturer's final investigation and corrections to a1 and g2.A1 - corrected patient identifier.G2 - checked "other" to add the country japan.Health professional should not have been checked on the initial report.The olympus service center found several technical defects such as a pinhole in the bending section cover, angle down and angle knob play, the switch button one cut, the air water cylinder paint peeling, a scratch on the objective and acoustic lens, insertion has a scratch, image shadow and the acoustic lens adhesive is chipped.A decomposition study revealed no traces of foreign bodies in each channel, but the air insufflation water button was found to be abnormal.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely the following contributed to the event: 1.Blood fluid refluxed into the scope tract during the case.2.Blood fluid retrograde into the tract coagulated and packed.3.Blood fluid coagulated and packed ducts could not be cleaned in the cleaning and disinfection process.4.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).5.Fluid in the tract was discharged from the nozzle as a foreign body before the case the specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13222507
• MDR Text Key: 292999222
• Report Number: 8010047-2022-01215
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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
• Patient Age: 43 YR
• Patient Sex: Female