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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sepsis (2067)
Event Date 08/19/2019
Event Type  Injury  
Manufacturer Narrative

The scope was not returned to the service center for evaluation. The cause of the reported event cannot be determined at this time. An investigation to obtain more detailed information regarding the reported events is ongoing.

 
Event Description

The service center was informed that during a reprocessing and infection control in-service conducted with an olympus endoscopy support specialist (ess), the user facility reported that two septic patients were admitted after undergoing procedures. The user facility reported that the scope is washed in water, its channel is also brushed in water, the scope is then placed in disinfectant, sterilized with glutaraldehyde for 30 minute, the scope is brushed again in high level disinfectant and finally rinsed off in water. The patients course of treatment is unknown. In addition, during the visit the ess observed the user facility¿s reprocessing methods and noted the following deviations: the facility was not correctly pre-cleaning, leak testing, using detergent, manual cleaning or storing the scope. The ess reported that facility does not currently have a leak tester, or storage cabinet. The ess covered infection control information referenced in the manufacturer¿s user manual and reprocessing manual. This report is for 1 of 2 patients.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTONEPHROFIBERSCOPE
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 Key9069991
MDR Text Key158643519
Report Number8010047-2019-03277
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 09/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/19/2019
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 Reuse

Patient TREATMENT DATA
Date Received: 09/16/2019 Patient Sequence Number: 1
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