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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 Problems Unspecified Infection (1930); Urinary Tract Infection (2120)
Event Date 11/10/2015
Event Type  Injury  
Manufacturer Narrative

This device referenced in this report has not been returned to olympus for evaluation. The exact cause of the reported event could not be conclusively determined at this time. The facility continues using the device, however there was no patient harm reported such as inflammation of the prostate. The service person checked the device with no irregularities found on the day the event was reported. The manufacturing history was reviewed with no irregularities found. Please cross reference the associated complaint file: mfr report#: 8010047-2015-01163.

 
Event Description

Olympus medical systems corp. (omsc) was informed that two patients having undergone urinary bladder and urethra inspection developed inflammation of the prostate from a nurse when the service person visited the facility. At that time when the two patients had endoscopic inspection, the facility used two cyf-va2s (serial #(b)(4) manufactured on sep. 6th in 2006 and #(b)(4) manufactured on jan. 6th in 2012) and the facility could not identify which scope was used to each patients. First patient (70's): about one week after having undergone endoscopic inspection, the patient developed fever. The patient came back to the facility and was diagnosed with inflammation of the prostate. The patient was infused antibiotic substance without being hospitalized. The patient became less severe. Second patient ((b)(6)): about ten days after having undergone endoscopic inspection, the patient developed fever. The patient came back to the facility and was diagnosed with inflammation of the prostate. The patient was hospitalized and was infused antibiotic substance. The patient was in follow-up.

 
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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 192-8 507
JA 192-8507
Manufacturer Contact
susumu nishina
2951
ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
6425177
MDR Report Key5269842
MDR Text Key32739374
Report Number8010047-2015-01162
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK#:K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 11/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberCYF-VA2
Device Catalogue NumberCYF-VA2
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 Received11/10/2015
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

Patient TREATMENT DATA
Date Received: 12/06/2015 Patient Sequence Number: 1
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