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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-VHA
Device Problem Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
Event Description
During an unspecified endoscopy, the user found that the glue of the distal end of the subject device was peeled off and fell off into the patient's body. The user continued to perform the endoscopy and completed the endoscopy as it is. According to the judgment of the doctor, the fell glue flake will be naturally excreted in urination without any problem because it was small. Therefore, the doctor did not perform additional treatment. Since then, there were no reports of patient injuries related to this incident.
 
Manufacturer Narrative
Olympus medical systems corp. (omsc) investigated the subject device and found the following about the subject device. The adhesive of the bending rubber was peeled off. There was a dent at the insertion tube. There was the residue of the chemical solution at the insertion tube. The light guide lens of the distal end was broken. The rust occurred at the screw of the venting connector. The device history record indicates that the subject device has been shipped in conformity to the specifications. The exact cause of the reported event could not be conclusively determined. However, omsc surmised the adhesive of the bending rubber was deteriorated or worn. There is a possibility that deteriorated or worn of the adhesive was attributed to eog sterilization. There were no further details provided. If significant additional information is received, this report will be supplemented.
 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9626408
MDR Text Key220877040
Report Number8010047-2020-01008
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VHA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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