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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-VHR
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

The scope has not returned to olympus for evaluation. The reported complaint cannot be confirmed. Despite several followup attempts, no further information is currently available regarding the infection, the procedure involved, the patient outcome, the specific scope involved, its pre-procedure inspection, or whether the scope device is returning to olympus for evaluation. An olympus endoscopy support specialist has since provided retraining to address the reprocessing issues that were a potential contributing factor. If additional information becomes available, this report will be supplemented accordingly.

 
Event Description

During a customer education session on manual cleaning and disinfection, olympus was informed that the user facility had experienced a prior infection incident involving this model scope. The actual scope serial number was not disclosed. The infection type, date of procedure and patient details were not disclosed. It was reported that prior to the education session, the scope reprocessing at the user facility had not been performing the leak test, was not completing pre-cleaning, did not have the appropriate cleaning brushes for the endoscope channels, did not take the irrigation port off between uses, and did not completely immerse the endoscope in high level disinfection.

 
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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
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8084768
MDR Text Key127856206
Report Number2951238-2018-00709
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHR
Device Catalogue NumberCYF-VHR
Was Device Available For Evaluation? No
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? Device Not Returned To Manufacturer
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: 11/19/2018 Patient Sequence Number: 1
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