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

Model Number CYF-V2

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

To resolve the reported problem, an olympus endoscopy support specialist (ess) was dispatched to the user facility to perform an onsite in-service in the correct reprocessing steps of the subject scope.The ess confirmed that, with the exception of not brushing the channel, the facility was performing the reprocessing steps correctly.The ess completed an in-service, which consisted of reprocessing training, including pre-cleaning, leak testing, manual cleaning and high level disinfection according to the olympus reprocessing manual.The instructions for use for the subject device contain instructions regarding how to perform the brushing of the scope channels.In addition, the following statements are provided in the subject scope's instructions for use: warning: all channels of the endoscope must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning, disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.Warning: be sure to brush the inside of the instrument channel and suction channel.Otherwise, insufficient cleaning, disinfection, and/or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.

Event Description

A user facility reported to olympus that users were missing reprocessing steps of the olympus, cyf-v2, visera cysto-nephro videoscope; specifically, it was noted that the users weren't brushing the channels.The user facility reported that there is no injury, death or infection associated with the reported problem.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.The device history record for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.Based on the available information, the investigation confirmed that the instructions for use were not followed.The following instructions are provided in the instructions for use: "all channels of the endoscope must be cleaned, and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope." ¿ "do not coil the endoscope's insertion tube with a diameter of less than 10 cm.Doing so may damage the endoscope." ¿" for proper reprocessing results, do not coil the insertion section with a diameter of less than 40 cm.If the diameter is less than 40 cm, it will be difficult to insert the channel cleaning brush (bw-15b) and/or the single-use channel cleaning brush (bw-201b).This may result in endoscope channel damage and/or insufficient cleaning." ¿ "when aerating or irrigating the endoscope channels, the air or water pressure must not exceed 0.2 mpa (2 kgf/cm2,29 psig).Higher pressures may cause damage to the endoscope." ¿ "before immersing the endoscope in detergent or disinfectant solution, confirm that the eto cap is not attached to the endoscope.If the eto cap is attached, water will be able to penetrate the inside of the endoscope, and it can be damaged.".

• 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: 11695233
• MDR Text Key: 246423915
• Report Number: 8010047-2021-05160
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1