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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.Physical evaluation of the complaint device reveals: the scope passed the dunk test.There was a stain in the oes image.The insertion tube coating was peeling near the it glue.There was missing red paint on the battery holder.The technician replaced all necessary components and the device has been restored to olympus original factory specifications.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
It is reported during maintenance of a cystonephrofiberscope, the clear covering was peeling off of the scope.There was no patient contact/impact related to this occurrence.
 
Manufacturer Narrative
Upon further review, this is a not reportable device malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to a death or serious injury should this malfunction recur.
 
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Brand Name
OES CYSTONEPHROFIBERSCOPE
Type of Device
CYSTONEPHROFIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11092139
MDR Text Key224584519
Report Number8010047-2020-11100
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
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 Manufacturer12/16/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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