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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned to the service center for evaluation. As part of our investigation, the customer was informed that the cyf-5 scope was only validated to be sterilized with the use of sterrad nx and eto gas. An olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary. To date, the ess visit has not been finalized. The instruction manual warns users in the ¿reprocessing and storage¿ section ¿these instruments were not disinfected or sterilized before shipment. Before using these instruments for the first time, reprocess them according to the instructions in chapter 5, ¿reprocessing: general policy¿ through chapter 7, ¿cleaning, disinfection and sterilization procedures¿. After using the instrument, reprocess and store it according to the instructions in chapters 5, through chapter 9. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance. ¿.

 
Event Description

The service center was informed that the user facility was not reprocessing the scope according to the manufacturer¿s recommendations. The user facility was using a steris 1e automatic endoscope reprocessor (aer). There was no patient involvement reported.

 
Manufacturer Narrative

This supplemental report is being submitted to report additional information. Additional information the customer states that the manufacturer of the facility¿s steris 1e automatic endoscope reprocessor (aer) was contacted to validate the use of the aer to reprocess the scope. However, the legal manufacturer of the scope reviewed the contents of this complaint and reported the following: it was confirmed that the following was mentioned in the operation manual. The stereoscopic 1e used in facility is a product without combinatorial ensure or validation. Also, when using a cleaning and disinfecting device other than our designation, it is necessary to confirm that the entire endoscope, including all pipelines of the product, can be cleaned and disinfected, and that the cleaning and disinfecting procedure thereof. · therefore, please contact the manufacturer of the device regarding the above matters. Olympus confirms validation of the endoscope reprocessors recommended by olympus only. (we do not assure the cleaning and disinfection efficacy of this product combined with endoscopic cleaning and disinfection equipment other than our designation. ) (2) if using endoscope reprocessor that are not recommended by olympus, the endoscope reprocessor manufacturers are responsible for validation of the endoscope reprocessor with the endoscope models listed in its intended use statement. (when using irrigation and disinfection equipment other than our designation, the entire endoscope containing all tracts of the product can be irrigated and disinfected, and the manufacturer of the equipment should be contacted for disinfection and disinfection procedures. ) in addition, the legal manufacturer recommends the customer follow the ifu instructions below. Chapter 8 cleaning and disinfection equipment the endoscope is compatible with some endoscope reprocessors recommended by olympus. Refer to the instruction manual of endoscope reprocessor for details on operation. Olympus confirms validation of the endoscope reprocessors recommended by olympus only. If using endoscope reprocessor that are not recommended by olympus, the endoscope reprocessor manufacturers are responsible for validation of the endoscope reprocessor with the endoscope models listed in its intended use statement. If using an endoscope reprocessor, confirm that it is capable of reprocessing endoscope including all channels. If there are channels and/or other parts which cannot be cleaned and high-level disinfected by the endoscope reprocessor, have to undergo manual cleaning and high-level disinfection or sterilization as described in chapter 7, ¿cleaning, disinfection and sterilization procedures¿ after using the endoscope reprocessor. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope. If you are uncertain as to the ability of your endoscope reprocessor to clean and high-level disinfect endoscope including all channels, contact the endoscope reprocessor supplier for specific instructions and/or connectors. Chapter 8 cleaning and disinfection equipment oes cystonephrofiberscope cyf-5/cyf-5a 89. Use connectors special to each model when cleaning and disinfecting the endoscope with the endoscope reprocessor. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope. The applicable connectors for each endoscope model should be listed in the automated endoscope reprocessor instruction manual. If your endoscope model is not listed in this table, please contact the manufacturer of the endoscope reprocessor. ".

 
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Brand NameFIBERSCOPE "CYF-5", EUROPEAN VERSION
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 Key10265003
MDR Text Key209814608
Report Number8010047-2020-04288
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/16/2020
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

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