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

Model Number CYF-VH

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation of the device determined that the reported issue was confirmed.It was found that the lens guide (lg) cover ring was detached from the device.The distal end bending section c body was determined to be detached and the ¿a-rubber¿ was found cracked.The identified parts were replaced and device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on evaluation findings, the reported issue was confirmed.The root cause of the issue was attributed to physical damage likely due to maintenance and or handling of the device.

Event Description

It was reported that the device was found to have a problem with the aspiration system.According to the reporter as described, there is a small ring that popped out where the cord of the device attaches.The issue was found during reprocessing.There was no patient involvement.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).Please see updated sections: g4, g7, h2, h3, h6 and h10.The device history records (dhr) for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.It was reported that the device was found to have a problem with the aspiration system.According to the reporter as described, there is a small ring that popped out where the cord of the device attaches.We are not able to determine a root cause for the reported failure, the device per dhr meets product standards.Potential cause of the reported failure was may be related to the adhesive strength.Root cause is currently under investigation.Per user¿s manual: before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5,¿troubleshooting¿.If this endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.This endoscope was not reprocessed before shipment.Before using this endoscope for the first time, reprocess it according to the instructions as described in the endoscope¿s companion ¿reprocessing manual¿ with your endoscope model listed on the cover.

• 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
• MDR Report Key: 10218016
• MDR Text Key: 199848919
• Report Number: 8010047-2020-03796
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1