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

Model Number CYF-VHR

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted to provide the customer's reported experience and the investigation findings.Investigation results: the device history record (dhr) for this device was reviewed and indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Physical evaluation of the complaint device reveals the distal end rubber is peeled off with exposed thread.The m-plug is cracked.Review of the instructions for use (ifu) shipped with the device provides the customer the following information related to this issue: important information ¿ please read before use caution: do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Conclusions: the root cause could not be identified.Based on the investigation results, the probable causes include: there is a possibility that the distal end was damaged because the adhesion strength of the distal end was weak; or the distal end may have been damaged due to age deterioration.

Event Description

It is reported during reprocessing of a cysto-nephro videoscope, the distal end was found to be peeling and flaking.There is no patient contact/impact related to this event.

Manufacturer Narrative

This report is being submitted to report corrected information in h6, and h10.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 10987130
• MDR Text Key: 227200324
• Report Number: 8010047-2020-10193
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1