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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Material Deformation (2976)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation findings: physical evaluation of the complaint device: a visual inspection of the returned device condition was performed and found, the bending section cover buckle/stretched. In order to test the bending section cover, the inspector placed the bending section between two fingers and proceeded to moderately pull the bending section cover from the insertion tube side up to the distal end. After releasing the bending section cover, it was noted that the cover became buckle/stretched, never returning to its original form. Additionally, the inspector tested the bending section, glue and cover as stated in the inspection standards. The ring gauge was passed over the distal end, and obstruction was found at the section of the bending cover that had become buckled. A review of the device history record (dhr) for the device was conducted and confirmed there were no abnormalities in manufacturing. The instructions for use (ifu) shipped with the device provide the user with the following information related to the reported event: chapter 3 preparation and inspection 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 conclusions: the definitive root cause for this event could not be identified. Investigation results suggest the following possible causes: device degradation. The device was 13 years and 9 months old. The rubber a had deteriorated, and the buoyancy occurred when the rubber was moving during procedure. External force: there is evidence that some external force was applied to the a rubber, damaging the a-rubber and contributing to the movement.
 
Event Description
It is reported during a cystoscopy using a visera cysto-nephro videoscope, the doctor felt more friction than normal. Upon removing the scope after the exam, the patient had some bleeding. The scope was examined by the customer after the procedure and it was noted on the tip of the flexible portion of the scope, the outer covering of the scope is raised, and formed a ring, and it is not smooth. The procedure was completed as planned. The patient had minimal amount of post-procedure bleeding. No treatment was required as a result of this. The patient's current condition is stable with no continued bleeding.
 
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Brand NameVISERA CYSTO-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 Key11130270
MDR Text Key225596239
Report Number8010047-2021-01004
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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