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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem No Patient Involvement (2645)
Event Date 02/21/2020
Event Type  Malfunction  
Manufacturer Narrative

The endoscope was returned to the service center for evaluation. A review of the service history indicated the scope was purchased on (b)(6) 2017 with no previous repair records. The evaluation observed the endoscope failed the leak test and found that the distal bending section cover was torn. In addition, the service group noted the bending section cover glue was cracked and the endoscope produced a stain defect on the image. Based on the report, the likely cause of the reported event was attributed to incorrect reprocessing.

 
Event Description

The service center was informed that during reprocessing, the endoscope was sterilized without the venting cap. There was no patient involvement reported.

 
Manufacturer Narrative

There was no contact with a patient as this was a brand new scope that was being reprocessed after the move into a new facility. This scope has not yet been used for a procedure. The endoscope has not yet been manually cleaned. A third party automated endoscope reprocessor (aer) machine (steris vpro serial: (b)(4)) was being used to reprocess the endoscope. There have not been any issues with the aer. The aer is also a brand new machine. The scope was being stored in a third party vpro approved container.

 
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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 Key9996966
MDR Text Key200778439
Report Number8010047-2020-02364
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 COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-5
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/25/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2020
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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