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

Model Number	GF-UCT180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scope was returned to the service center and is pending evaluation and microbial testing.The cause of the reported event cannot determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.
Event or Problem Description
The customer reported that during maintenance the scope was cultured and tested klebsiella pneumoniae after several cleanings.There was no associated patient infection reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the reporter.The cleaning, disinfection, and sterilization (cds) techniques were provided by the customer.The scope was not ethylene oxide sterilized (eto).The following cleaning and disinfectant solutions were used with the endoscope; first step ep-6, medichoice enzymatice presoak and cleaner enz001, medivator rapicide pa part a, medivator rapicide pa part b, and medichoice isopropyl alcohol 70%.The minimum effective concentration was being checked for each scope.The endoscope channel was being brushed during manual cleaning with olympus single-use combination cleaning brush, bw-412t and olympus single use soft brush, (b)(6).Pre-cleaning was being performed immediately after a procedure.The pre-cleaning was performed per the instructions for use (ifu) from olympus.Double cleaning was performed.The endoscope was being leak tested prior to manual cleaning with an olympus maintenance unit, mu-1.The scope was never dropped or came in contact with a hard surface.The automated endoscope reprocessor (aer) used to reprocess the endocscope was the medivator dsd edge, sn (b)(6).No problems were noted with the aer.The last preventive maintenance for the aer was in (b)(6) 2021.The last date of the reprocessing in-service conducted by an olympus endoscopy support specialist (ess) was on (b)(6) 2021.There has been no change in the facilities reprocessing personnel since the last on-site visit by an olympus endoscopy support specialist.All reprocessing personnel were trained on how to properly reprocess an endoscope.The endoscope was being stored hanging in a drying cabinet.An olympus ess has been dispatched to observe the user facility¿s reprocessing practices from start to finish and provide a reprocessing in-service training, if necessary, to correct and address any reprocessing deviations.The device was received by olympus and has been sent to an independent laboratory for testing.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
Additional information was received from the reporter.The scope tested positive for klebsiella pneumoniae, enterobacter hormaechei, and pseudomonas aerusinosa.There was no known patient involvement.All brushings and flushes were put in one (1) container per the food and drug administration (fda) guidelines.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation, legal manufacturer's final investigation and the hygiene microbiological investigation report.After the device was returned to olympus, it was sent out for additional testing.The hygiene microbiological investigation report indicated that bacteria were detected in the tip, forceps rising, air supply and water supply pipes, balloon pipes, and forceps channel pipes.The device was evaluated where no abnormalities were found though there were several technical defects such as a large tear mark on the biopsy channel, damaged bending section cover glue, rust inside air-water cylinder, and a stain on the distal cover.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 6 years since the subject device was manufactured.Based on the results of the investigation, it is not possible to determine the relationship between the device in question and the positive culture event.This information is addressed in the instructions for use (ifu): "¦chapter 6 compatible reprocessing methods and chemical agents ¦chapter 7 cleaning, disinfection, and sterilization procedures" olympus will continue to monitor the field performance of this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: 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: 12871575
• Report Number: 8010047-2021-15033
• Device Sequence Number: 5941955
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 11/26/2021; 03/30/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 02/28/2022; 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown