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

Model Number CYF-VH

Device Problem Material Discolored (1170)

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

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted to provide information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation it was found that the gas sterilization or sterrad sterilization was performed for the endoscope to which foreign objects were adhered, resulting in black residues forming on the distal tip.It was found that the sink for cleaning in the facility was not exclusive to cleaning of the endoscopes.The result of the component analysis showed that the rubber/copper derived components were detected from the above sink used for cleaning the endoscope.A test was performed to verify that black residues on the distal tip were not microorganism contamination.The above components (foreign objects) were adhered to the distal tip of the endoscope while cleaning it.This information is addressed in the instructions for use (ifu): "6.6.2_ labeling review:chapter 1 general policy 1.1 instructions.This manual contains the reprocessing methods recommended by olympus for the endoscopes and accessories listed on the front cover.This instruction manual contains essential information on reprocessing endoscopes and accessories safely and effectively.Before reprocessing, thoroughly review this manual and the manuals of the reprocessing equipment and chemicals that will be used for reprocessing.Reprocess all the devices as instructed.Note that the complete instruction manual set for the endoscope and accessories consists of this manual and the ¿operation manual¿ with your endoscope model listed on the cover.Both manuals accompanied the endoscope at shipment.Keep this manual and all related manuals in a safe and accessible location (e.G., in the reprocessing area).If you have any questions or comments about any information in this manual, or if a problem that cannot be solved occurs while reprocessing, contact olympus." olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus that the device had a black residue forming on the distal tip.This black residue can also be seen on the cleaning tubes they use within hospital sterilisation and decon unit.The reported problem was found during reprocessing.No patient involvement or injury was reported.

• Brand Name: 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14760661
• MDR Text Key: 302694435
• Report Number: 8010047-2022-10500
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2022

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-VH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• 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