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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-VA2
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 12/19/2017
Event Type  Injury  
Manufacturer Narrative

The two cyf-va2 were returned to omsc for evaluation. The evaluation found following failures. [cyf-va2, s/n (b)(4), manufactured on september 13, 2015]. There were kinks in the instrument channel and the insertion tube. There were debris and scratches inside of the instrument channel. There were scratches on the rubber of the bending section. The part of the coating over the insertion tube was peeling off. [cyf-va2, s/n (b)(4), manufactured on november 11, 2010]. There were kink in the instrument channel and the insertion tube, the universal cord and the instrument channel. There were scratches inside of the instrument channel. There were scratches on the rubber of the bending section and the adhesive of bending rubber. There was debris on the universal cord. Omsc reviewed the manufacture history of the two cyf-va2 and confirmed no irregularity. The exact cause could not be determined at present. If significant additional information is received, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that 8 patients had a fever after a cystoscopy using subject device. The 8 patients reportedly experienced cystoscopy between (b)(6) 2017 and (b)(6) 2018. The facility provided unspecified medical treatment for the patients, but there was no information of the outcome. The facility possesses two cyf-va2 (serial number: (b)(4)), but it is unknown which scope was used for each patient. The user facility conducted microbial culture test for two cyf-va2 and the testing indicated no microbial growth for two cyf-va2. The user facility reported that the subject device had been reprocessed using endostream, a non-olympus automated endoscope reprocessor model. This report is 7 of 8 reports.

 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7243347
MDR Text Key99084819
Report Number8010047-2018-00154
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VA2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
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

Patient TREATMENT DATA
Date Received: 02/06/2018 Patient Sequence Number: 1
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