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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION HD FLEXIBLE CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEM CORPORATION HD FLEXIBLE CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VH
Device Problems Degraded (1153); Material Disintegration (1177)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 04/17/2015
Event Type  Malfunction  
Event Description

Olympus was informed that after the completion of a diagnostic cystoscopy procedure, it was observed that tissue fibers were coming out of the tip of the scope at the distal end. It was also reported that some of the distal end cover glue had fallen into the patient and was not retrieved by the physician. The physician believed that the device fragments will be flushed out naturally. There was no patient injury reported and intended procedure was completed using same device. It was further reported that during previous cleaning of the device there were several pieces of the black adhesive at the distal end of the device missing. No further information has been provided.

 
Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed that a portion of the bending section cover glue was missing from the distal end causing the device to fail leak test. This type of damage is most likely due to either improper handling or damage that can occur during reprocessing. The device was serviced and returned to the user facility.

 
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Brand NameHD FLEXIBLE CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCO
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192- 8507
JA 192-8507
Manufacturer Contact
noemi schambach
2400 ringwood avenue
san jose, CA 95131
4089355002
MDR Report Key4749181
MDR Text Key5770871
Report Number2951238-2015-00220
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 04/17/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
Device Catalogue NumberCYF-VH
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/22/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/17/2015
Was Device Evaluated By Manufacturer? Yes
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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