MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The olympus scope was sent to an independent laboratory for culture testing and results are still pending.After culture testing, the device will be evaluated.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The customer confirmed that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.Sampling was conducted immediately after reprocessing and the device was not used for any procedures after testing positive.The device was reprocessed 4 times before sampling.The customer provided the cleaning, disinfection, and sterilization process stating that precleaning was performed immediately after the procedure.Air/water was aspirated through the instrument/suction channel with a suction pump and the forceps elevator was raised/lowered three times in water during aspiration.During manual cleaning, pre-soaking was performed and the detergent used was anyor.A passing leak test was performed.The instrument/suction channel was brushed and the distal end was brushed with the single use cleaning brush.The device was rinsed before manual disinfection.The disinfectant used was tristel fuse and the channels were flushed with rinsed water.The concentration and expiration date of the disinfectant was controlled.The automated endoscope reprocessor (aer) used was stella with tristel fuse detergent and tristel fuse disinfectant.There were no reported defects on the aer and all channels were connected with tubes when the endoscope was setting up in the aer.The filter was replaced periodically in accordance with the instructions for use.The device was not dried and was stored in a simple cabinet.Olympus is the maintenance company.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the cystonephrofiberscope had a problem holding the angulation brake and wheel, and during routine microbiological testing, tested positive for >100 colony forming units (cfus)/100ml of contamination.All channels were sampled.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 results of third-party testing, the device evaluation and the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: dec 08, 2023.Sampling from: all channels.Cfu: <1cfu.Bacterial identification: n/a.The device was evaluated where no abnormalities were found that could have led to the positive culture and the reported phenomenon of holding of the angulation break and wheel could not be reproduced.The following defects were noted: defect of the bending section rubber cement.Insertion section mount unit is damaged.Defective passing of the forceps.However, these defects alone are not considered severe enough to cause a potential adverse event.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, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18314839
• MDR Text Key: 330939559
• Report Number: 3002808148-2023-14171
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2018
• 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