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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEM CORPORATION VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2R
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2015
Event Type  Malfunction  
Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation. The exact cause of the reported user's experience could not be conclusively determine at this time. The instructions for use warns users: if the angulation control mechanism or any other part of the system is not functioning properly, stop the procedure immediately and place the up/down angulation lock in the free "f " position. Then carefully withdraw the endoscope while observing the endoscopic image. If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it; leave it inside the patient and immediately contact olympus. Forcibly withdrawing the endoscope may cause patient injury. " if additional information is received or if the device is returned at a later time, this report will be supplemented.

 
Event Description

Olympus was informed that during a diagnostic cyctoscopy procedure, the physician was about to view the bladder when the bending section became irreversibly locked while inside the patient's urethra. As the physician began flexion of the device, a "snap" was heard and the bending section continued to flex and would not return to the straight position. It was reported that the device was stuck inside the patient for close to two hours. The insertion tube was manually cut in half to release the flexion and allow for removal of the device from the patient. There was no patient injury reported, just minor bleeding. The physician aborted the procedure and did not continue after the scope was removed. No additional information was provided.

 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer Contact
donny shapiro
2400 ringwood avenue
san jose, CA 95131
4089355161
MDR Report Key5324811
MDR Text Key34287182
Report Number2951238-2015-00630
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK133538
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 12/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberCYF-V2R
Device Catalogue NumberCYF-V2R
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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