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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5A
Device Problem Insufficient Information (3190)
Patient Problem Fever (1858)
Event Date 07/07/2016
Event Type  Injury  
Manufacturer Narrative

This device referenced in this report has not been returned to olympus medical systems corp. (omsc) for evaluation. Omsc reviewed the manufacture history of the subject device and confirmed that there was no irregularity related to the event found. The exact cause of the reported event could not be conclusively determined at this time, however, insufficient reprocessing as the user facility commented could not be ruled out as a contributory factor of the event. If additional information becomes available at a later time, this report will be supplemented.

 
Event Description

Preoperative inspection of the patient with cystocele was performed using the subject device. Olympus was informed that the patient developed a fever on the following day of the inspection. According to the user facility, other devices other than the subject device were all disposable products. Further, the user facility thought that the subject device caused the fever because it considered the cleaning of the subject device to be insufficient. Since olympus received a request for a study meeting about cleaning and disinfection from the user facility, it was held on july 12, 2016. The user facility continues using the subject device. The patient has been recovered as of july 26, 2016.

 
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Brand NameCYSTONEPHROFIBERSCOPE
Type of DeviceCYSTONEPHROFIBERSCOPE
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 Key5845998
MDR Text Key51111016
Report Number8010047-2016-01070
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK#: K032092
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 08/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberCYF-5A
Device Catalogue NumberCYF-5A
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 Received07/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2014
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: 08/04/2016 Patient Sequence Number: 1
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