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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 Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The scope was returned to the service center for evaluation. The cause of the reported event cannot be determined at this time.

 
Event Description

The service center was informed during reprocessing the parts from the distal end of the scope fell off. The user facility reported the defect was not present in the previously completed procedure. At the time of the event occurred there was no patient involvement.

 
Manufacturer Narrative

The device was returned to the service center for evaluation. The bending section glue was found cracked. A hole/cut was noted on the bending section rubber resulting in a leak. The light was dim due to 15 percent of the fibers being broken. The scope image was checked and found to be foggy. The legal manufacturer reviewed the content of this complaint for further investigation. The legal manufacturer was unable to the legal manufacturer reported that the most like causes for the reportable event are as follows: since rubber a was broken, it is assumed that an external force was applied to the distal end, which resulted in damage. It is presumed that the above-mentioned damage led to leakage of the actual product. Due to the occurrence of a leak, moisture invaded the inside of the product, and the ig bundle was detached, resulting in an abnormal image. However, imaging abnormalities may be due to a separate charge-coupled device (ccd) failure. Alternatively, the manufacturing date of the current product was august 3, 2010, which may be due to the aging degradation of the components. However, the above is presumed because there is no delivery of the current product, a photograph of the failure state, or a photograph of the failure image. The dhr (shipment test record) was checked to ensure that the current product was shipped under normal conditions. Important information ¿ please read before use warnings and cautions follow the warnings and cautions given below when handling this instrument. This information is to be supplemented by the warnings and cautions given in each chapter. Never perform angulation control, suction control or insertion/withdrawal of the endoscope¿s insertion tube without viewing the endoscopic image. Patient injury, bleeding and/or perforation can result. Never insert or withdraw the endoscope¿s insertion tube while the up/down angulation is locked. Patient injury and/or equipment damage can result. Although the illumination light emitted from the endoscope¿s distal end is required for endoscopic observation and treatment, it may also alter living tissues by, for example, causing protein denaturation of liver tissue, or perforation of the intestines. Observe the following warnings with regard to illumination. Always set the minimum required brightness. Keep in mind that the brightness of the image on a video monitor may differ from the actual brightness at the distal end of the endoscope. Pay close attention to the brightness level setting of the light source, particularly when operating the electrical shutter function of a video system. When using a light source and video system that are compatible with the light source¿s automatic brightness control function, make sure to use the function. The automatic brightness control function can better maintain the illumination light level. Refer to the instruction manual of the light source and the video system for further details.

 
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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 Key10279465
MDR Text Key223651296
Report Number8010047-2020-04452
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 09/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated By Manufacturer? Yes
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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