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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The referenced device was not returned for evaluation. Additionally, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results. However, the investigation is ongoing; if additional information becomes available, this report will be supplemented accordingly.
 
Event Description
The service center was informed, during inspection prior to a diagnostic procedure the cysto-nephrofiberscope's "rubber coating on the very end has come off". There was no patient injury or harm reported.
 
Manufacturer Narrative
This supplemental report was submitted to provide additional information from the legal manufacturer. The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria. No abnormalities were found. The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode. Since no device was returned for evaluation; the root cause of the reported malfunction could not be conclusively determined. However, it is possible that the malfunction may have been attributed to external force was applied to bending section cover and the coating came off and fell. As stated on the ifu (instruction for use) and as a preventive measure, the warnings and cautions section user manual states: 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. The legal manufacturer will continue to monitor the field performance of this device.
 
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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 Key11883062
MDR Text Key268351898
Report Number8010047-2021-06746
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
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? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2008
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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