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

Model Number CYF-VH

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was tested and visually inspected, results identified a leak/cut during leak testing and minor dents and scratches were observed from visual inspection.Visual inspection also revealed bending section of the device was detaching and adhesive presented cracks likely due to physical damage.The device was serviced and returned to the user facility.

Event Description

The customer reported that a loose joint was noticed during a procedure by the surgeon.The customer reported there was no patient harm.It was reported that the surgeon completed the case with the same device without any delay in procedure.

Manufacturer Narrative

This supplemental report was submitted to provide new information from the original equipment manufacturer (oem) investigation.A review of the device history record (dhr) confirmed the subject scope was shipped in accordance with specifications via dhr.Per instructions for use: 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¿.Warning using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause is suspected as a possibility of external force applied during handling, leading to a leak.Olympus will continue to monitor the field performance of this device.

• 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: 10141248
• MDR Text Key: 194887845
• Report Number: 8010047-2020-03257
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

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: Other
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1