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 05/24/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the uretero-reno fiberscope tested positive for unexpected contamination.The scope was sampled once.During the sampling, the scope tested positive for 1 colony forming units (cfus) of sphingobium spp.And 1 cfu of brevundimonas spp.The issue was found at reprocessing during a routine culture of the scope.All channels were tested.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

The device was sent to an independent laboratory for culture testing.The device tested positive for 2 colony forming units (cfus) of bacillaceae which is not conforming to standard.The scope will be reprocessed, and a new culture sample will be taken prior to device return for evaluation.The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer did confirm 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.The specific steps taken at the facility during the cleaning sterilization and disinfection (cds) process were not provided by the customer.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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: sep 28, 2023; sampling from: all channels; cfu: 2 cfu/endoscope (3 cfu/100ml); bacterial identification: bacillaceae.Sampling date: oct 19, 2023; sampling from: all channels; cfu: 2 cfu/endoscope (3 cfu/100ml); bacterial identification: micrococcaceae.The device was evaluated where no abnormalities were found that could have led to the positive culture.The following defects were noted: bending tube metal braid --- damaged, mouthpiece --- damaged, control unit mount --- damaged, biopsy channel --- incised, cuts, image guide bundle --- 4 back dots.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.The following is included in the device ifu: "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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17916264
• MDR Text Key: 326259859
• Report Number: 9610595-2023-15008
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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-P7
• 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: 09/17/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• 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