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

Model Number URF-V3

Device Problem Microbial Contamination of Device (2303)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

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 device was rinsed before manual disinfection.The channels were flushed with and immersed into the disinfectant.The water quality used was sterile water.The concentration and expiration date of disinfectant was controlled.The device was dried by wiping with a sterile paper and by filtered compressed air.The endoscope was stored in sterile drapes.Prior to any maintenance, the endoscope is cleaned and disinfected according to the recommendations.The customer followed the national regulation (instruction no.Dgos/pf2/dgs/vss1/2016/220 of july 4, 2016, relating to the treatment of temperature-sensitive flexible endoscopes with channels in healthcare settings) which adheres to the instructions for use.Prior to device evaluation, the olympus scope was sent to an independent laboratory for culture testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured and less than 1 colony forming units (cfus) of any microbes were found.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of a positive culture was not confirmed.In addition, the bending section cover glue separated.The biopsy channel was incised with cuts.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, during reprocessing, the uretero-reno videoscope on (b)(6) 2023 tested positive for micrococcus luteus colony forming units (cfus) of 1.A retest on (b)(6) 2023, showed the presence of microbacterium paraoxydans and stenotrophomonas maltophilia cfus of 6.The final test on (b)(6) 2023 showed the presence of microbacterium paraoxydans cfus of 6.All channels were sampled.The user did not report any 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.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 VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 17333857
• MDR Text Key: 319139719
• Report Number: 9610595-2023-10195
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170435119
• UDI-Public: 04953170435119
• 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,Followup
• Report Date: 08/14/2023

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-V3
• Device Catalogue Number: N5782022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• 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