MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.Processing manager states that the device was brought to their facility in november of 2019.An olympus endoscopy support specialist (ess) performed a scope reprocessing and infection control in-service for facility.During the in-service the facility manager states that the scope has not been leak tested since brought to their facility in november of 2019.The ess covered infection control information referenced in the user manual and reprocessing manual.Including: "after precleaning, perform a leakage test on the endoscope to ensure that it is waterproof by using the leakage tester mb-155 or wa23070a." after reviewing reprocessing steps processing manager at facility confirmed scope will be leak tested after each use moving forward.This report will be updated accordingly if additional and significant information is received at a later time.

Event Description

The user facility requested quarterly training and in-service.No adverse event reported in association with this report.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-03457.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there was no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to leakage testing process not being conducted at the facility.According to the instruction manual, it is stated that the leakage testing must be performed before use.For the above, it is possible that the leakage testing could not have been done in the facility by human errors.After precleaning, perform a leakage test on the endoscope to ensure that it is waterproof by using the leakage tester mb-155 or wa23070a.Equipment needed prepare the following equipment.When performing a leakage test using mb-155, prepare the following equipment.Do not use a damaged or leaking endoscope.Use of a damaged or leaking endoscope may pose an infection control risk to the patient and operators.Never connect or disconnect the leakage tester¿s connector cap while immersed.Doing so could allow water to enter the endoscope and equipment damage can result.Personal protective equipment, such as eyewear, mask, moisture-resistant clothing, and chemical-resistant gloves.Basins that are at least 40 cm by 40 cm (16¿ by 16¿) in size and deep enough to completely immerse the endoscope.Clean water.Leakage tester.Do not use a damaged or leaking endoscope.Use of a damaged or leaking endoscope may pose an infection control risk to the patient and operators.

• Brand Name: VIDEOSCOPE "CYF-V2", EUROPEAN VERSION
• 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: 10169862
• MDR Text Key: 198680116
• Report Number: 8010047-2020-03457
• Device Sequence Number: 1
• Product Code: FAJ
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1