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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-V2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); Swelling (2091)
Event Type  Injury  
Event Description

The service center was informed by the user facility¿s performing doctor that the patient experiences an allergic reaction after undergoing repeat cystoscopy procedures. Due to a pre-existing condition, the patient must undergo a cystoscopy every three months. The patient experiences swelling of the penis and purple discoloration. The patient has no pre-existing allergies. The patient was given topical cream to treat the reaction. The doctor reported that the patient¿s condition last approximately two or three weeks. The doctor reported that only ky lubricant is used. There are no other lubricants, creams, or soaps used during the procedure. This patient is an isolated case, no other patients have been noted with this reaction. The doctor did not know the specific serial number for the referenced scope; therefore, it is unknown if the scope was returned to olympus for evaluation/service and a review of the instrument¿s history could not be performed. The service center did follow up with the user facility to obtain the following additional information: the disinfectant/solution used to reprocess the scope and the patient¿s procedure date; however, this information was not provided. As part of our investigation, the content of this complaint has been escalated to the original equipment manufacturer (oem) for further investigation.

 
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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 192-8 507
JA 192-8507
MDR Report Key9507369
MDR Text Key172581254
Report Number2951238-2019-01229
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 11/27/2019,12/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/27/2019
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer11/27/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/20/2019 Patient Sequence Number: 1
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