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

Model Number GF-UCT180

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled and one (1) colony forming unit of unspecified microorganisms were detected.The obtained results are in conformance with the requirements.The customer provided additional information regarding the cleaning, disinfection and sterilization processes performed onsite for the endoscopes.During pre-cleaning, the customer the customer suctions water from the channels and flushes the air/water, auxiliary washing, balloon and forceps channel.During the pre-cleaning, the customer uses an unspecified detergent.During manual cleaning, the customer uses detergent aniozme x3 and brushes the operating/suction channel, suction piston, port of the operating channel, balloon channel and the distal end/area found the elevator.The customer uses brushes the customer manually disinfects the scope using anioxyde 1000.Model number of the brush used is teccare enr kit2-04-200-y (lot 2110050) and teccare en00015-10b (lot 201108).Automatic endoscope reprocossor (aer) soluscope 4, along with detergent soluscope cln and disinfectant soluscope paa.The customer is stored horizontally.Olympus is not the customer¿s maintenance company.The scope was not sterilized.The evaluation of the device is currently pending.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the evis exera ii ultrasound gastrovideoscope tested positive for under 61 colony forming units (cfus) of microorganisms.All channels were sampled and citrobacter freundii was identified.The issue occurred during reprocessing.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found though there were several technical defects such as the distal sheath adhesives are worn and peeling off, deformed cables, interference with brush and treatment device and part of the insertion tube is caught and pinched from user handling issues.These defects were not considered severe enough to cause a potential adverse event and are likely due to wear and tear damage from use over an extended period of time.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, it is unlikely the positive culture was caused by the device.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.This information is addressed in the instructions for use (ifu): "warning: thoroughly clean and high-level disinfect or sterilize the endoscope before returning it for repair.Improperly reprocessed equipment poses an infection control risk to each person who handles the endoscope within the hospital or at olympus." olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13040427
• MDR Text Key: 284375092
• Report Number: 8010047-2021-16385
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• 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