MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VIDEOSCOPE "CYF-V2", UK VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Calcified (1077)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical assistance center (tac), the customer reported the presence of calcium buildup on the videoscope.The customer reported using manual cleaning and disinfection process, and an alcohol-based disinfectant.As the customer also reported that hard water is used at the facility, tac informed the customer that the only solution would be to use a water softener at the facility.It was concluded that the buildup was a result of the user disinfectant and hard water.The device is not expected to be returned at this time.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that there was calcium buildup on the videoscope "cyf-v2" (uk version).The issue occurred during reprocessing, there was no delay, and the diagnostic procedure (cystpscopy) was completed with the same set of equipment.There was no patient harm associated with the event.

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, the root cause of the event was unable to be identified; however, it was confirmed in the customer's report that calcium had accumulated in the scope.The facility uses hard water for reprocessing.(calcium and magnesium are highly included in hard water).The event can be detected/prevented by following the instructions for use which state: "do not reuse rinse water.To remove the detergent solution from the endoscope and accessories completely, rinse them enough in clean water (potable water, water that a microbe was removed by a filter, de-ionized water, sterile water, etc.).Once removed from disinfectant solution, the instrument must be thoroughly rinsed with sterile water to remove any residual disinfectant.If sterile water is not available, clean, potable tap water or water that has been processed (e.G., filtered) to improve its microbiological quality may be used.When nonsterile water is used after disinfection, wipe the endoscope and flush the channels with 70% ethyl or isopropyl alcohol, then air-dry all internal channels to inhibit the growth of bacteria." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to the legal manufacturer contact and facility registration number.

• Brand Name: VIDEOSCOPE "CYF-V2", UK VERSION
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; GM 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16013926
• MDR Text Key: 308112645
• Report Number: 9610773-2022-00696
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

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: CYF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/30/2023; 05/03/2024
• Supplement Dates FDA Received: 02/20/2023; 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2012
• 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