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

Model Number CYF-V2

Device Problem No Display/Image (1183)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/06/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.The olympus service center has evaluated the device and confirmed the reported issue, lines on image.The lines are caused by the build-up of foreign matter, possibly fluid under the lens, typically a result of user handling.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported the device malfunctioned during an unknown procedure and the procedure needed to be abandoned because there were image issues, lines on the screen.The device was inspected prior to the procedure and no issues were found but the customer reported the image issue is hard to identify if not in use.The customer reported there was no harm to the patient due to cancelling the procedure after a local anesthetic gel was applied.The patient's procedure was re-scheduled, completed and no further issues.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the damaged cable.Olympus will continue to monitor field performance for 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: 14782887
• MDR Text Key: 295038196
• Report Number: 8010047-2022-10612
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2014
• 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
• Patient Outcome(s): Other