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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE Back to Search Results
Model Number CYF-VA2
Device Problem Device Reprocessing Problem (1091)
Patient Problem Fever (1858)
Event Date 07/17/2012
Event Type  Injury  
Manufacturer Narrative

Because olympus confirmed that there were 5 patients involved in the reported event, olympus will submit additional 4 initial mdrs to account for the total of 5 patients. (please cross reference 8010047-2012-00223, 8010047-2016-00176, 8010047-2016-00178, 8010047-2016-00179) olympus followed up with the user facility to obtain additional information regarding this report. The user facility reported that the three patients were admitted but have already been discharged. The other two patients were diagnosed with noninfectious pyrogenic urethritis. The subject device was returned to olympus for evaluation. The evaluation found a slight residue in the instrument channel port and the distal end. Omsc disassembled the subject device for evaluation. As a result of the disassembly evaluation, kink and perforation were found in the instrument channel. The kinked instrument channel is surmised to be caused by the deflected insertion tube. Because the instrument channel became narrower due to the kink, it is considered that interference between an instrument and the instrument channel increased upon insertion of the instrument, and it lead to the perforation. Trace of water invasion was noted inside the control section. Omsc conducted a composition analysis on foreign material noted on the subject device. As the result of the composition analysis of the foreign material found on the instrument channel port, o (oxygen) and slight amount of cl (chlorine) were detected in addition to stainless steel, the base metal. It suggests that a part of the instrument channel port was corroded by tap water or some other factors. As the result of the composition analysis of the white foreign material found on the distal end, na (sodium) and cl (chlorine) were detected. They are seemingly the residue of cleaning detergent, etc. As the result of the composition analysis of the black foreign material found on the distal end, c (carbon), sn (tin), p (phosphorus), si (silicon), and cl (chlorine) were detected. It was confirmed that they were to be the same element as the antifriction material used inside the subject device. Based on the above, the exact cause of the reported event could not be conclusively determined, but inadequate user reprocessing, inadequate maintenance, or user handling could not be ruled out as a contributory factor.

 
Event Description

The user facility reported that five patients returned to the user facility complaining of fever after having undergone a cystoscopy. The patients were provided with unspecified antipyretic treatment.

 
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Brand NameOLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP
2951 ishikawa-cho
hachioji-shi
tokyo 192-8 507
JA 192-8507
Manufacturer Contact
kunimori yamaguchi
2951 ishikawa-cho
hachioji-shi
tokyo 
JA  
MDR Report Key5385191
MDR Text Key36625231
Report Number8010047-2016-00177
Device Sequence Number0
Product Code FAJ
Combination Product (Y/N)
Reporter Country CodeJA
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 01/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2016
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VA2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2012
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2012
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/22/2016 Patient Sequence Number: 1
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