MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

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, after a microbiological routine culture on the uretero-reno fiberscope, an unexpected contamination was detected.There was no reported contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Event Description

Additional information was received from the reporter.All channels were sampled.The uretero-reno fiberscope tested positive for one (1) colony forming unit (cfu) of staphylococcus epidermidis.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the reporter and the cleaning, disinfection, and sterilization (cds) checklist performed by the customer.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.The sampling was routine.The automatic endoscope reprocessor (aer) was sampled/cultured, however the test report was not available.The flushing of the air/water channel, auxiliary water channel, and forceps elevator wire channel were precleaned without detergent.The instrument/suction channel, instrument channel port, and the distal end/areas around the elevator were manually cleaned with olympus bw-400b single-ended cleaning brushes.The scope was not manually disinfected.The scope was however disinfected with anioxyde 1000 disinfectant every procedure.The scope was not sterilized.The maintenance was performed by olympus.

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 7 years since the subject device was manufactured.Based on the results of the investigation, a relation could not be judged between the event and the device from the investigative results.When the culture was tested after reprocessing in accordance with the instructions for use (ifu) before repair, the growth of microorganisms was not confirmed.No non-conformity was identified that required repair on the subject device.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 12923104
• MDR Text Key: 284615651
• Report Number: 8010047-2021-15475
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2018
• 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