MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problems Microbial Contamination of Device (2303); Failure to Clean Adequately (4048)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the forcep elevator channels and all channels of the scope were cultured and less than 1 cfu of any microbes were found.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device evaluation found that the nozzle was clogged with foreign material.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

It was reported that, during reprocessing, the ultrasound gastrovideoscope tested positive for microbiological contamination five times.On the first sampling, testing tested positive for 4 colony forming units (cfus) of micrococcus luteus, 4 cfus of staphylococcus capitis, and 1 cfu of staphylococcus warneri in all channels.On the second sampling, testing detected 7 cfu moraxella osloensis and 3 cfu micrococcus luteus in the forceps elevator wire channel.The third sampling, testing detected 1 cfu of staphylococcus epidermidis in all channels.In the fourth sampling, testing detected 2 cfu staphylococcus warneri, 1 cfu paenibacillus pabuli, and 2 cfu staphylococcus non aureuss in the forceps elevator wire channel.On the final sampling, testing detected 9 cfus of staphylococcus warneri in all channels.The user did not report any contamination or any other serious deterioration in state of health of any person, to which this medical device could have been a contributory cause.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, the device evaluation and the lms final investigation.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.Olympus provided the following result of the culture test, performed at the third-party labs: culture examination results at the third-party organization: the parts where bacteria were detected: distal end of the channel.Total amount of detected bacteria: 3 cfu.Microbe name: bacillaceae (amount of bacteria: unknown).The device was evaluated where an additional potential adverse event was noted where foreign material remained clogging the nozzle.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 likely bacteria were found due to improper reprocessing caused by the blocked nozzle however, the foreign material could not be identified nor the root cause of why it remained.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the ifu before repair, the results conformed to the regulation's recommendation.As a result of confirming the contents of the instruction manual of gf-uct180, reprocess method is described on the items below.Chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18902001
• MDR Text Key: 337859912
• Report Number: 3002808148-2024-02405
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2818-2015
• Patient Sequence Number: 1