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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
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.
 
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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 Key10141248
MDR Text Key194887845
Report Number8010047-2020-03257
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170310461
UDI-Public04953170310461
Combination Product (y/n)N
PMA/PMN Number
K062049
Number of Events Reported1
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 NumberCYF-VH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/15/2020
Initial Date FDA Received06/10/2020
Supplement Dates Manufacturer Received08/10/2020
Supplement Dates FDA Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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