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 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

After the device was returned to olympus, it was sent out for additional testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured.Less than one (1) colony forming unit (cfu) of microorganisms was identified.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The cleaning, disinfection, and sterilization (cds) was performed by the customer.Aniosyme x3 was used as pre-cleaner when swabbing.Between each endoscopic procedure, there was a semi-automatic procedure of aniosyme x3 in a five (5) minute bath with swabbing and brushing of the endoscope.The scope was then cleaned in the soluscope automatic endoscope reprocessor (aer) in a long cycle (double cleaning / disinfection).For the manual cleaning, the scope was put in a five (5) minute bath of aniosyme x3 then disinfected in an oxide 1000 bath (10 minutes + 5 minutes) on the anios manual bench.Soluscope paa product was used for manual cleaning with soluscope cln disinfectant.The biopsy valve was cleaned in the same manner.Aseptinmed swabs model number 201790 were used.The scope was stored vertically in an hysis as300x2 eset storage cabinet.Maintenance was performed by olympus for endoscopes, anios for the bench and soluscope, and hysis for thermosensitive endoscope (eset).The subject device has been received and is currently in the evaluation process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported by the customer, the evis exera ii ultrasound gastrovideoscope was sampled, and an unexpected contamination was detected.The issue was found during a routine culture.There was no 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 supplemental report is being submitted to provide additional information from the reporter and the device evaluation.The device was evaluated.The reported issue was not confirmed per the hygiene microbiological investigation.During inspection, it was noted the insulation of the probe unit was out of range.The bending section cover was worn out.The connecting tube was wrinkled.The suction cylinder and air/water cylinder were scratched, and the forceps wire riser was stretched.

Event Description

Additional information was received from the reporter.The scope channels were sampled and tested positive for greater than two hundred (200) colony forming units (cfus) of various bacteria; stenotrophomonas maltophilia, serratia marcescens, coagulase-negative staphylococci, and achromobacter.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 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: 12915984
• MDR Text Key: 285151295
• Report Number: 8010047-2021-15408
• 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,Followup
• Report Date: 04/06/2022

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-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 01/31/2022; 03/10/2022
• Supplement Dates FDA Received: 02/04/2022; 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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