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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP CYSTO-NEPHRO VIDEOSCOPE CYSTO SCOPE

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OLYMPUS MEDICAL SYSTEMS CORP CYSTO-NEPHRO VIDEOSCOPE CYSTO SCOPE Back to Search Results
Model Number CYF-VHA
Device Problems Device Reprocessing Problem (1091); Device Operates Differently Than Expected (2913)
Patient Problem Unspecified Infection (1930)
Event Date 04/01/2015
Event Type  Injury  
Event Description

Olympus medical systems corp (omsc) was informed that 2 patients developed cystitis after having undergone cystoscopy procedure. The patients were cured with antibiotics. One of the patients was male in his sixties. The attending physician commented that insufficient reprocessing might have caused the cystitis. There were a total of 5 cystic scopes including 2 loaned devices. It was unk which device was used to each patient.

 
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. If additional information, or if a device is received at a later time, this report will be supplemented. The manufacturing history was reviewed, with no irregularities related to this problem noted. Please cross refence the associated complaint files: mfr report#: 8010047-2015-00363, 8010047-2015-00364, 8010047-2015-00387, and 8010047-2015-00388.

 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO SCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP
2951 ishikawa-cho
hachioji-shi, tokyo 192- 5807
JA 192-5807
Manufacturer Contact
susumu nishina
2951 ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
26425177
MDR Report Key4781828
MDR Text Key5819793
Report Number8010047-2015-00389
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 04/22/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2015
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
Date Manufacturer Received04/22/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 05/15/2015 Patient Sequence Number: 1
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