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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number OLYMPUS CYF-5A
Device Problem Insufficient Information (3190)
Patient Problem Irritation (1941)
Event Date 10/27/2016
Event Type  Injury  
Manufacturer Narrative

The subject device was not returned to omsc for evaluation. The manufacturing record of the device was reviewed without irregularity. The facility reported that the patient had developed a rash due to a disinfectant solution used for the endoscope in earlier days. As above, the exact cause of the reported event could not be determined at present. However, the possibility cannot be ruled out that the patient indicated an allergic reaction to a disinfection solution used for the subject device. If significant additional information is received, a supplemental report will follow.

 
Event Description

Olympus medical system corp. (omsc) was informed that a patient developed redness around the opening of the urethra after having a procedure with the subject device. After the procedure, the patient presented to a dermatologist and got recovered. It is unknown whether facility completed the procedure. The facility thinks that there is no relation between the subject device and the reported event at this time.

 
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Brand NameOLYMPUS
Type of DeviceOES CYSTONEPHROFIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 ishikawa-cho
hachiouji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer Contact
nishina susumu
2951 ishikawa-cho,
hachioji-shi, tokyo 192-8-507
JA   192-8507
6425177
MDR Report Key6172928
MDR Text Key62323487
Report Number8010047-2016-01531
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 12/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberOLYMPUS CYF-5A
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 Received11/15/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2014
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: 12/14/2016 Patient Sequence Number: 1
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