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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VHA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative

The subject device has not returned to olympus medical systems corp. (omsc) for evaluation yet. There were no further details provided. If significant additional information is received, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that the user facility found three patients were infected with unspecified microbes on (b)(6) 2020. The three patients underwent endoscopic procedures using cyf-vha on (b)(6) 2020. The patients' outcome is reportedly as follows. First patient: fever. Second patient: fever and hospitalization. Third patient: unknown. The cyf-vha had been reprocessed with an olympus automated endoscope reprocessor model oer-s using peracetic acid. The concentration of disinfectant of the oer-s was effective. The user wipes the cyf-vha with a sterile cloth after automated reprocessing cycle and stores the device in the basin of the oer-s until next procedure. Olympus is submitting 3 medwatch reports for the cyf-vha. This is the 1st of the 3 reports.

 
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Brand NameCYSTO-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
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10183026
MDR Text Key201048926
Report Number8010047-2020-03568
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2011
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: 06/23/2020 Patient Sequence Number: 1
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