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  

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 to capture unspecified amount of patients: (b)(6).

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and no reportable device defects were found that could have led to the reported positive culture.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, when olympus culture tested (via 3rd party lab) the device before reprocessing, the biopsy suction channel was positive for pseudomonas stutzeri (>20 colony forming units).However, after reprocessing in accordance with the instructions for use (ifu) before repair, the device was negative for microbial contamination.It is likely that the reported incident (pseudomonas contamination) was due to insufficient reprocessing of the device caused by deviation from the ifu manual.However, a relationship between the subject device and the reported patient infections (urinary tract infections) could not be identified.Therefore, the root cause could not be determined, the event can be detected/prevented by following the instructions for use (ifu) in sections: chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.An update has been made to d9 and h3.Also, additional information has been added to b5 and h4.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that it is unknown if a forceps/irrigation plug (maj-891) was involved in the event.However, the customer stated that when used, they disassemble the maj-891 and cystoscope and plunge the maj-891 with the same disinfectant solution used for the cystoscopes.They do not brush the device, but only rinse it before introducing in the disinfectant solution.

• 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: 18424293
• MDR Text Key: 331859858
• Report Number: 9610595-2024-00012
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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: 12/04/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2010
• 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