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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 Problems Device Reprocessing Problem (1091); Problem with Sterilization (1596); Contamination /Decontamination Problem (2895)
Patient Problem No Code Available (3191)
Event Date 08/19/2019
Event Type  Injury  
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.

 
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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
MDR Report Key9070007
MDR Text Key160322066
Report Number2951238-2019-01116
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
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? Yes
Date Report Sent to FDA09/16/2019
Distributor Facility Aware Date08/19/2019
Event Location Hospital
Date Report TO Manufacturer08/19/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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