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

Model Number URF-V2

Device Problem Microbial Contamination of Device (2303)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

The customer reported that the uretero-reno videoscope had failed the hygiene test during a routine culture of the scope.The olympus scope was sent to an independent laboratory for culture testing.All channels sampled tested positive for two colony forming units (cfu) of an unknown micro-organism.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

After the device was returned to olympus, the scope was sent to an independent laboratory for culture testing and the customer's allegation was confirmed.The instrument channel of the scope tested positive for one colony forming unit (cfu) of coagulase-negative staphylococci.As a result of the test results, the scope will undergo additional culturing, which is currently pending.The customer provided their cleaning, disinfection, and sterilization process.Pre-cleaning is performed by aspiration of water through the instrument/suction channel, and the forceps elevator wire channel is flushed.The instrument/suction channel and distal end/areas around the elevator are manually cleaned with aniosyme detergent, using an asept inmed brush.The scopes are manually disinfected with anioxide 1000.The scopes are sterilized daily with anioxyde 1000.The scopes are stored horizontally after treatment.Maintenance is performed by olympus.The physical device evaluation has not yet been completed.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.A defect was noted where the master case was cracked, however, this defect alone is 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 instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "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 field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 13694930
• MDR Text Key: 288210922
• Report Number: 8010047-2022-04105
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

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: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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