MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Material Erosion (1214)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Upon discovering the incorrect reprocessing, the user facility immediately stopped using the scope and will send to olympus for repair.To date, the device has not been received.Facility will be receiving a new hld product.Additionally an in-service was scheduled for olympus personnel to properly instruct the user facility.However, the in-service was cancelled by the user facility due to covid-19.Olympus technical assistance center personnel will contact the customer in regards to rescheduling the in-service.At this time it does not appear the device will be returned.However, should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.

Event Description

During a device reduction and repair evaluation conducted by an olympus endoscopy support specialist, when evaluating the visera cysto-nephro videoscope the device appeared to have rust at the distal tip, the covering appeared to be deteriorating.It is possible the damage is due to incorrect reprocessing.The device was used on patients.The user facility is using resert for high level disinfection.The user facility reported that they had been using the scopes until they failed the leak test or produced no image.At this time, no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿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.¿ the root cause could not be determined.Probable causes include improper reprocessing of the device.Since rust occurred at the distal end from the tip of the subject product to the a-rubber, there is a possibility that correct reprocessing was not performed.Olympus will continue to monitor the field performance of this device.

Event Description

Additional information was received on 25feb2021 noting that the event occurred during reprocessing.As reported, this did not lead to any delays in a procedure.There was no evidence that the issue started after changing the hlb from the first solution to the second.The reprocessing personnel have not been changed since the last on-site visit from an oiympus field service engineer.According to the reporter, all proper reprocessing steps were taken.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11368717
• MDR Text Key: 244119835
• Report Number: 8010047-2021-02907
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1