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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/22/2019
Event Type  Injury  
Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that three patients developed fever after cystoscopy using an olympus cysto-nephro videoscope (cyf-vha or cyf-va2). First patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-vha) on (b)(6) 2019. It was reported that the patient developed fever on (b)(6) 2019. Second patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-vha) on (b)(6) 2019. It was reported that the patient developed fever on (b)(6) 2019. Third patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-va2) on (b)(6) 2019. It was reported that the patient developed fever on (b)(6) 2019. The three patients¿ condition is currently unknown. The olympus cysto-nephro videoscopes (cyf-vha and cyf-va2) had been reprocessed with an olympus automated endoscope reprocessor, oer-4 (not available in the usa), using peracetic acid. It was reported that forceps/irrigation plug was not completely disassembled during reprocessing. Omsc is submitting three medical device reports according to the number of the patients. This is one of three reports.

 
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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 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 Key8835736
MDR Text Key152484609
Report Number8010047-2019-02720
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/24/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/25/2016
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: 07/29/2019 Patient Sequence Number: 1
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