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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 Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
The subject device has not been returned to any of olympus locations. Therefore. Olympus could not investigate the subject device. Omsc could not confirm the manufacturing history (dhr) of the subject device because the serial number of the subject device was unknown. Based upon the information from olympus (b)(4), omsc surmised that the reported event was caused by the use of the subject device with bacterial residue to patients. It was also surmised that since the validity of the reprocessing methods of the subject device at the user was confirmed, the cause of the cause of the bacterial residue was not attributed to the subject device. And, as the results of the microbiological tests performed by the user facility on (b)(6) 2021, no microbes were detected on any cystoscopes (cyf-5), so it was also surmised that inappropriate reprocessing just before this event might have resulted the bacterial residue on 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. 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 (b)(6) before cystoscopy procedures: serial number (b)(4): pseudomonas aeruginosa. Serial number (b)(4): pseudomonas aeruginosa. Serial number (b)(4), serial number (b)(4), serial number (b)(4), and 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), serial number (b)(4), and 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), serial number (b)(4), serial number (b)(4), serial number (b)(4), serial number (b)(4), serial number (b)(4), serial number (b)(4), and 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: these 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 had been used an olympus irrigation plug maj-891. This report is regarding cyf-5: serial number unknown (3 of 3).
 
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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 Key12108016
MDR Text Key267555510
Report Number8010047-2021-08333
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 foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCYF-5
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 Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/02/2021 Patient Sequence Number: 1
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