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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 Failure to Clean Adequately (4048)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the service center for evaluation. The customer¿s complaint of ¿foreign material was falling from the channel¿ was not confirmed as the channel was found to clean and free of debris. The bending section rubber was found leaking due to multiple cuts and upon removing the bending section rubber excessive frayed wires were noted on the bending mesh. An investigation is ongoing to obtain additional information regarding the reported event and to determine the possible root cause.
 
Event Description
The user facility reported that foreign material was falling from the channel. There was no patient involvement reported. No further information was provided.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer investigation. Please see the updates in sections. The legal manufacturer (lm) reviewed the content of this complaint for further investigation. The legal manufacturer was unable to determine the root cause. As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation. It was confirmed that there was no unevenness. The actual product was shipped in a normal condition. The lm reported that the most probable cause for the reported event is as follows: it was presumed that the rubber a fell from the forceps channel as it became a foreign object due to the broken bending section rubber. The actual product was manufactured on april 14, 2011, and it may have been affected by aging degradation since about 9 years and 8 months have passed.
 
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Brand NameOES CYSTONEPHROFIBERSCOPE
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 Key11173447
MDR Text Key235015204
Report Number8010047-2021-01403
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2021
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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