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 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

The cleaning, disinfection, and sterilization (cds) of the scope was performed by the customer.There was no patient infection.The automatic endoscope reprocessor (aer) was cultured/tested, however, the results were not available.The channels were flushed.There was an aspiration of water through the instrument/suction channel as well.The instrument channel port was manually cleaned with ddn9 detergent and an olympus bw - 400b single use channel cleaning brush.The scope was manually disinfected with anioxyde 1000.The scope was stored horizontally.The maintenance of the scope was performed by olympus.The scope was not sterilized.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.Four (4) cfus of gram-positive bacteria (bacilles) and micrococcaceae were detected.The results obtained did not comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.An additional culture will be conducted.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

The customer reported to olympus, a routine microbiological culture was performed on the uretero-reno fiberscope.On (b)(6) 2022, and (b)(6) 2022, all channels tested positive for one (1) colony forming unit (cfu) of a microorganism.There was no contamination or any other serious deterioration in the 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 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 4 years since the subject device was manufactured.Based on the results of the investigation, a relationship between the subject device and the event could not be identified.No deviation from the instructions for use (ifu) was confirmed from the review of the reprocessing steps provided from the user.The root cause could not be determined.The event can be detected/prevented by following the instructions for use which state: important information; please read before use."an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." this supplemental report includes information added to d8 and h4.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: 14594173
• MDR Text Key: 293656209
• Report Number: 8010047-2022-09374
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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: 05/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2017
• 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