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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-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
The subject device is planned to be returned to olympus but has not been returned to olympus yet. Therefore, olympus could not investigate the subject device. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed following information from the user facility. There was an outbreak of pseudomonas aeruginosa infections associated with cystoscopies performed at the user facility urology outpatient clinic. As a result of microbiological testing by the user facility, the same microbes (pseudomonas aeruginosa) as the causative microbes of the reported infections were detected from the sample collected from each of four cystoscopes (cyf-5: serial number (b)(4), cyf-5: serial number (b)(4), cyf-5: serial number (b)(4), and cyf-5: serial number (b)(4)). The user facility performed cystoscopies using these four cystoscopes on (b)(6). The user facility did not provide other detailed information such as the number of microbes. These four cystoscopes had been manually reprocessed using peracetic acid, and reprocessed with a non-olympus automated endoscope reprocessor, sterado. The user facility performed the microbiological test of sample collected from the examination room where the procedures had been performed and no bacteria was detected. The user facility performed additional microbiological tests and no bacteria was detected from the sample collected from each of these four cystoscopes, and the cystoscopes were sterilized. There were no reports on the number of infected patients, their current health condition, or correspondence between the reported infections and the device serial numbers at this time. This report is 1 of 4, and regarding cyf-5: serial number (b)(4).
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. Olympus medical systems corp. (omsc) obtained the following additional information from the user facility: number of patients infected and current condition: as of (b)(6) 2021, six cases of urinary tract infection after cystoscopy procedures using cystoscopes (cyf-5) had been identified as follows: five patients with pseudomonas aeruginosa infection (four of these patients required hospitalization/ two presented bacteremia/ one required intensive care). One patient with a proteus mirabilis infection required hospitalization (possible endogenous patient flora). There were no deaths resulting from the infections. All patients had been discharged from hospital. Correspondence between infected patients and cystoscope. The correspondence between infected patients and used cystoscopes (cyf-5) was as follows: three cases of infection without knowledge of the used cystoscope (two procedures performed on (b)(6); one procedure performed on (b)(6)). One case of pseudomonas aeruginosa infection after using serial number (b)(4). The procedure performed on (b)(6). One case of pseudomonas aeruginosa infection after using serial number (b)(4). The procedure performed on (b)(6). One case of proteus mirabilis infection after using serial number (b)(4). The procedure performed on (b)(6). Microbiological test results: the results of microbiological tests performed by the user facility on used cystoscopes were as follows: tests performed on april 19 before cystoscopy procedures: serial number (b)(4): pseudomonas aeruginosa, serial number (b)(4): pseudomonas aeruginosa, serial number (b)(4): no microbes were detected, and these cystoscopes were sterilized. Tests performed on (b)(6) before cystoscopy procedures: serial number (b)(4): stenotrophomonas maltophilia, serial number (b)(4): pseudomona aeruginosa and pseudomonas luteola, serial number (b)(4): stenotrophomonas maltophilia, serial number (b)(4): no microbes were detected, and these cystoscopes were sterilized. Tests performed on (b)(6): all cyf-5 used by the user facility (serial number (b)(4)): no microbes were detected, and these cystoscopes were sterilized. Tests performed on (b)(6): serial number (b)(4): no microbes were detected, and this cystoscope was sterilized. Others: the user facility had been used an olympus irrigation plug maj-891. The subject device has not been returned to any of olympus locations. Therefore. Olympus could not investigate the subject device. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. Based upon the information from olympus europa (b)(4), omsc surmised that the reported event was caused by the use of the subject device with bacterial residue to patients. And, since there was no abnormality in the dhr of the subject device and the validity of the reprocessing methods of the subject device at the user was confirmed, it was surmised that the cause of the bacterial residue was not attributed to the subject device. In addition, microbes were detected in the first and second microbiological tests performed by the user facility, but no microbes were detected in the third microbiological test. Therefore, it was surmised that microbes remained due to insufficient reprocessing, because there was possibility that reprocess according to the instruction manual had not been sufficiently performed by the user facility. If additional information is received, this report will be supplemented.
 
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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 Key11910860
MDR Text Key262175107
Report Number8010047-2021-06920
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberCYF-5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/31/2021 Patient Sequence Number: 1
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