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

Model Number CYF-V2

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Due diligence has been executed for this event.Event date is not known.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during an unknown procedure, the device rubber tip was hanging loose.When the piece was put back in place, the device did not feel comfortable to use.There was reported harm or adverse impact to the patient.

Manufacturer Narrative

The actual device has not been evaluated as it was not available for evaluation.Evaluation has been done by historical data.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.There is no occurrence of this phenomenon caused by product or manufacturing, and there is no frequent occurrence of this phenomenon.The reported issue of the device was that the device rubber tip was hanging loose.Since the actual device is not available for evaluation nor was there any information available from the customer, root cause for this issue cannot be determined.It is likely one or the other, or both of the scenarios below could have occurred: (1) external force was applied to the distal end, which resulted in damage.(2) damage resulted as a result of aging.The instructions for use includes the following statements: before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 9.3, returning the endoscope for repair on page 123.If any irregularity is observed after inspection, follow the instructions given in chapter 9, troubleshooting.Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.In addition, information provided on the initial report is being corrected.The following sections were updated: b5, d4, d10, g4, g7, h2, h3, h4, h6 and h10.The device was returned to an olympus service center for evaluation.This supplemental report is to inform that 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.

Event Description

On the initial report, section b5 indicated, ¿there was reported harm or adverse impact to the patient¿.This statement is being corrected to indicate, ¿there was no reported harm or adverse impact to the patient¿.

• Brand Name: VISERA 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: 10667035
• MDR Text Key: 223663076
• Report Number: 8010047-2020-07571
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

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: No Information
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 12/21/2020
• Supplement Dates FDA Received: 11/13/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1