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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 Problem Local Reaction (2035)
Event Type  Injury  
Manufacturer Narrative

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. This event has been reported by the importer on report # 2951238-2019-01229.

 
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. In addition, the user facility reported that they are not 100% sure that this is related to the scope.

 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9507500
MDR Text Key189053582
Report Number8010047-2019-04509
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2020
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? No
Event Location No Information
Date Manufacturer Received12/22/2019
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 Initial

Patient TREATMENT DATA
Date Received: 12/20/2019 Patient Sequence Number: 1
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