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

Model Number URF-V

Device Problem Microbial Contamination of Device (2303)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, during a routine microbiological control, the uretero-reno videoscope tested positive for four colony forming units (cfus): 1 cfu of haematobacter massiliensis and 3 cfu of moraxella spp.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

Additional information has been requested regarding this event.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 tested positive for less than one (1) colony forming units (cfus)/ endoscope of microorganism.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.Also, there was no damage to the subject device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

Correction to h10 of the initial report.The olympus third-party culture resulted in less than 1 cfu and was negative for any germ indicators.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Despite good faith attempts the user cleaning disinfection and sterilization (cds) processes were not shared.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.As a result of confirming the contents of the instruction manual about shipping products, it is described about reprocessing method on the items below: chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Chapter 8 maintenance procedures of equipment for reprocessing.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17719201
• MDR Text Key: 323061132
• Report Number: 3002808148-2023-09646
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072957
• 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: 10/17/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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