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 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation and the investigation is in process.The physical device evaluation has not yet been completed.After the device was returned to olympus, it was sent out for additional testing.The analysis report indicated the scope was cultured.Seven (7) cfu of pseudomonas spp.And micrococcaceae were detected.The scope was reprocessed, and the second set of test results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The customer provided their cleaning, disinfection, and sterilization processes.Pre-cleaning is performed by aspirating water through the instrument/suction channel.The air/water channel, auxiliary channel, balloon channel, and forceps elevator wire channel, are flushed.Anios clean excel d detergent is used for precleaning.Manual cleaning is then performed by brushing the instrument/suction channel, suction cylinder, instrument channel port, balloon channel, and the distal end/areas around the forceps elevator, with an lta ebi brush and anios clean excel d detergent.Manual disinfection is performed using anioxyde 1000 disinfectant.The scopes are sterilized with hydrogen peroxide using a v-pro max2 sterilizer.Their storage practice is horizontal placement in a simple storage cabinet.Olympus is the maintenance company.Once the investigation has been completed, a supplemental report will be submitted with the results of the device evaluation.

Event Description

The customer reported to olympus that during routine testing, the endoscope tested positive for microbial contamination.All channels were sampled and 2 colony forming units (cfu) of micrococcus luteus were detected.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 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.Additionally, multiple defects were noted: the distal end of the insertion part was burned.The connector was cracked.The distal end of the insertion part of the biopsy channel was incised and had cuts however, these defects 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 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): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15112319
• MDR Text Key: 304432718
• Report Number: 9610595-2022-00327
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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