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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 Problem Sepsis (2067)
Event Date 10/18/2018
Event Type  Injury  
Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation. There was no malfunction report of the subject device. Since the serial number of this device is unknown and omsc could not confirm the manufacturing history. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that a patient developed sepsis after a cystoscopy using the subject device. The patient was discharged from the user facility after the cystoscopy, but the patient visited the hospital again due to difficulty in urination and was diagnosed with sepsis. Dialysis was carried out for the patient hastily. The user facility commented that urinary tract¿s infection was possibly caused by the cystoscopy and resulted in the sepsis. The user facility reprocessed the subject device using olympus automated endoscope reprocessor model oer-s (not available in the usa. ) the outcome of the patient is currently unknown.

 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key8072879
MDR Text Key127208417
Report Number8010047-2018-02206
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 02/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2018
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
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

Patient TREATMENT DATA
Date Received: 11/15/2018 Patient Sequence Number: 1
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