MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P7

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.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 uretero-reno fiberscope initially tested positive for 1 colony forming unit (cfu) of the unspecified microorganisms.The device was sampled and tested again after five days.The second test result was positive for 1 cfu of the unspecified microorganisms.The device was sampled and tested again after six days of seconded sampling.The third test result was positive for 2 cfus of the unspecified microorganisms.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 the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, and the device evaluation.Correction to b3.The lm reviewed the customer provided cds processes where information to judge deviation from the instructions for use (ifu) was not identified.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2024.Sampling from: all channels.Cfu: 1cfu.Bacterial identification: bacillaceae.Sampling date: (b)(6) 2024.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.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 ifu before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: ifu warns on insufficient reprocessing by stating ¿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 FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19061132
• MDR Text Key: 340472870
• Report Number: 9610595-2024-07279
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435096
• UDI-Public: 04953170435096
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181451
• 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
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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