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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 08/26/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to omsc for the evaluation. Omsc checked the subject device and confirmed that a small part of the distal end rubber of the subject device had been peeled off and gone. The exact cause has been under investigation, therefore 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
Olympus medical systems corp. (omsc) was informed that a piece of rubber fell off from the subject device to inside the patient's body during the unspecified procedure. The user retrieved a piece of rubber from the patient and changed to the similar device and completed the procedure. There was no report of the patient injury.
 
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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 Key10557860
MDR Text Key207886008
Report Number8010047-2020-06690
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2015
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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