MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VA2

Device Problem Failure to Clean Adequately (4048)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

The device has not yet been received for evaluation.The devices have been re-processed and stored as they always are.Pre-cleaning was performed immediately after the patient procedure.Water was not aspirated through the instrument/suction channel with a suction pump.The instrument/suction channel was brushed.The device was not rinsed before manual disinfection.All channels were flushed with and immersed into the disinfectant.The concentration and expiration date of disinfectant were controlled.The aer/ewd used was minietd2.There were no defects on aer/ewd.All channels were connected with tubes when the endoscope was setting up into the aer/ewd.The concentration and expiration date of disinfectant were controlled.The water quality of the rinse water was controlled.After processing, the device was not dried.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus, there was leakage and pseudomonas contamination with the visera cysto-nephro videoscope.The microbiology test reported a positive sample.Patients with infection began to arrive, the amount of patients or type of infection was not specified.It was identified that these patients had recently undergone cystoscopy procedures, therefore the cystoscopes and washing machines were tested, and one of the scopes tested positive.Around 20 days prior, customer had performed culture tests in all the devices and the results were correct.Related patient identifier: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to the initial with information inadvertently left out (b5), to provide an update with information received through follow up (h10), and to provide an update to fields (d9, h3, and h4).The device was evaluated by olympus.It was determined that the subject device had a pseudomonas contamination.Additionally, there were non-reportable (non-pae) defects noted.Despite good faith attempts the user culture results were not shared.Olympus provided the following result of the culture test, performed at the third-party labs: sampling (prior to cleaning, disinfection, and sterilization of cyf-va2 by olympus): sampling date: (b)(6) 2024.Sampling from: sampling solution instrument/biopsy/suction channel cfu: >20.Bacterial identification: pseudomonas stutzeri.Sampling (prior to cleaning, disinfection, and sterilization of cyf-va2 by olympus): sampling date: (b)(6) 2024.Sampling from: sampling of swabbing distal end unit.Cfu: 0 cfu.Bacterial identification: no detection.Sampling (after cleaning, disinfection, and sterilization of cyf-va2 by olympus): sampling date: (b)(6) 2024.Sampling from: sampling solution instrument/biopsy/suction channel and sampling of swabbing distal end unit.Cfu: 0 cfu.Bacterial identification: no detection.The following provides additional information received: the customer could not confirm if the maj-891 (forceps/ irrigation plug) was used.Additionally, the user explained that they usually disassemble and plunge in the same disinfectant solution they use with the cystoscopes.The users do not brush and only rinse before introducing in the disinfectant solution.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, the relationship between the subject device and the infection cannot be confirmed.It is likely the suggested event occurred due to deviation from the instruction manual and the reprocessing was insufficient.However, the root cause of the suggested event could not be identified.The event can be prevented by following the instructions for use which state: - chapter 6 compatible reprocessing methods and chemical agents - chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.

Event Description

The subject device was reprocessed by minietd2 on the previous day and stored as usual (wrapped in a soaker and hung on the work cart).The sample was obtained the next morning.The user did not exam the positive device again, however; the subject device was sent in for repairs.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO 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: 18472121
• MDR Text Key: 332381157
• Report Number: 9610595-2024-00480
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VA2
• 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: 12/13/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2010
• 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
• Treatment: MINIETD2 REPROCESSOR.
• Patient Outcome(s): Other