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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-V2R
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/26/2016
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. Visual inspection showed that the bending section rubber glue was cracked. The cause of the reported complaint was unable to be determined. The most likely cause of the reported complaint was user mishandling of the device.

 
Event Description

Olympus was informed that during a diagnostic cystoscopy procedure, a small piece of glue remained inside the patient's bladder. The surgeon attempted to remove the glue but was unsuccessful. The decision was to let the glue stay in the bladder and will eventually evacuate through urination. The intended procedure was completed with the same device. There was no patient injury reported. The patient was discharged to home without any complication.

 
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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
donny shapiro
2400 ringwood avenue
san jose, CA 95131
408935-516
MDR Report Key5507068
MDR Text Key40560871
Report Number2951238-2016-00315
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberPK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/17/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2R
Device Catalogue NumberCYF-V2R
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/01/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2016
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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