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

Model Number CYF-V2

Device Problem Use of Device Problem (1670)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Following the procedure, the olympus sales representative informed the staff not to use high level disinfected items in a sterile procedure.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The olympus sales representative reported the clinician used two high level disinfected flexible videoscopes during a sterile procedure.The sales representative was observing the procedure when this occurred.There was no death, injury, or infection reported for this event.This report records the first videoscope used during the procedure.The report with patient identifier (b)(6) records the second videoscope used.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the sales representative and to provide the results of the manufacturer's investigation.The following fields were updated with information from the olympus sales.As part of the investigation, a review of the instructions for use (ifu) was conducted.The ifu contains the following statement regarding sterilization followed by the procedure: "the endoscope can be sterilized by ethylene oxide gas.".The serial number was not be provided and could not be confirmed.A review of the device history record could not be conducted.The root cause of using the high level disinfected scopes could not be confirmed.Olympus will continue to monitor the field performance of this device.

Event Description

Additional information was provided by the olympus sales representative on 22sep2021.The serial numbers are unknown.The procedure was a percutaneous nephrolithotomy.The procedure was completed successfully and there was no harm or impact to the patient.

• Brand Name: VIDEOSCOPE "CYF-V2", UK 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: 12377718
• MDR Text Key: 268483327
• Report Number: 8010047-2021-10851
• 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
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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: 07/28/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1