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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VHA
Device Problem No Apparent Adverse Event (3189)
Patient Problem Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative

The subject device was returned to olympus for evaluation. The evaluation confirmed foreign materials within the instrument channel port and a deformation in the instrument channel of the subject device. Omsc reviewed the manufacture history of the subject device and confirmed no irregularity the exact cause could not be determined at present, but the insufficient reprocessing by the user facility cannot be ruled out as the cause of this event.

 
Event Description

Olympus medical systems corp. (omsc) was informed that three of six patients, who undergone unspecified cystoscopy with the subject device, suffered mild prostatitis since they purchased the subject device on (b)(6) 2018. It was reported that the three patients were treated with antibiotic and in good condition after the procedure. The facility reported that they had used another cystoscope before (b)(6) and there was no prostatitis. Omsc followed up with the facility to obtain additional information. The facility reported that they manually reprocessed the subject device using glutaraldehyde and the subject device passed the leakage test during reprocessing. In addition following deviations from the instructions of the subject device were reported from the facility. -the facility did not use medical detergent solution but a detergent solution for household. -they did not attached adapter to the channels of the subject device during the reprocessing and they flush the channels directly using running water. This is one of three repots.

 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7633183
MDR Text Key112140659
Report Number8010047-2018-01208
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/18/2018
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: 06/25/2018 Patient Sequence Number: 1
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