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 second videoscope used during the procedure.The report with patient identifier (b)(6) records the first videoscope used.

Event Description

Additional information received from the sales rep on (b)(6) 2021.The serial numbers are unknown.The procedure was a percutaneous nephrolithotomy (pcnl).The procedure was completed successfully and there was no harm or impact to the patient.

Manufacturer Narrative

Additional information was received from the reporter.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, it is likely that the issue was due to misuse.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "visera cysto-nephro videoscope cyf-v2/va2/v2r chapter 4 operation [warning] the endoscope must always be sterilized before using for percutaneous nephroscopy." olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12377761
• MDR Text Key: 268482967
• Report Number: 8010047-2021-10853
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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