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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE

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OLYMPUS MEDICAL SYSTEM CORPORATION CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/05/2015
Event Type  Injury  
Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation. As part of our investigation into this report, olympus dispatched an endoscopy support specialist (ess) to the user facility to observe their reprocessing techniques. A date has not been set yet for this visit. The exact cause of the patient's outcome could not be conclusively determined at this time. If additional information becomes available at a later time, this report will be supplemented. The instruction for use states, "failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety. To minimize the risk of transmitting diseases from one patient to another, after each procedure that endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization as described in chapter 7, cleaning, disinfection, and sterilization procedures. Reprocess not only the external surface of the endoscope but also all channels. " please cross reference mfr numbers; 2951238-2015-00505, 2951238-2015-00506, and 2951238-2015-00507.

 
Event Description

Olympus was informed that four patients developed pseudomonas infection after undergoing a cystoscopy procedure. The user facility reported that two to three days after the procedure, the four patients returned to the facility with the same symptom of burning during urination (urinary tract infection). Urine samples were collected from all four patients, and all tested positive for pseudomonas. Antibiotics were immediately administered to the four patients. All four patients tested negative post antibiotics and are doing well. The user facility reported that the scope was cleaned with revitalox resert. No further information was provided. This is one of four reports.

 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho,
hachioji-shi, tokyo,, 192-8 507
JA 192-8507
Manufacturer Contact
noemi schambach
2400 ringwood avenue
san jose, CA 95131
4089355002
MDR Report Key5182093
MDR Text Key29403402
Report Number2951238-2015-00504
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation MEDICAL ASSISTANT
Type of Report Initial
Report Date 10/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Device Catalogue NumberCYF-V2
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2015
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: 10/27/2015 Patient Sequence Number: 1
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