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 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled.The device tested positive for one (1) colony forming unit of unspecified micro-organisms.Gram-positive bacteria was identified.The obtained results are in conformance with the requirements.The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.During pre-cleaning and manual cleaning, the customer uses detergent salvanios premium.During pre-cleaning, water is suctioned out of the channels and rinses out the air/water, auxiliary, balloon and forceps channel.During manual cleaning, the customer brushes the operating/suction channel, suction piston, operating channel port, balloon channel and the distal end/area around the elevator using asept inmed brushes (reference (b)(4)).The scope was manually disinfected using salvanios premium.For automatic endoscope reprocessing, the user facility uses aer soluscope 4, along with detergent soluscope cln and disinfectant soluscope paa.The customer tests the aer but did not provide test results.The endoscopes are stored in a drying cabinet and olympus is the maintenance company the user facility uses.The scope was not sterilized.The device is currently being evaluated.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 gastrointestinal videoscope tested positive for more than 25 colony forming units (cfus) of mesophilic flora.The issue was found during a routine culture of the scope.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 bending section cover is leaking and glue separating, damaged lens, the connecting tube is wrinkled, the scope cover is cracked, the switch box unit is scratched, the bending tube has movement and the pipe is deformed.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.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, the relation between the event and the device could not be confirmed.Though lower than that standard value, growth was confirmed after reprocessing in accordance with the instructions for use (ifu).This information is addressed in the instructions for use (ifu): "reprocessing manual: 1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." 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: 13084826
• MDR Text Key: 285967576
• Report Number: 8010047-2021-16814
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• 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: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2017
• 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