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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 referenced scope was returned to the service center for an evaluation. The evaluation found that the scope passed the insulation and leakage tests. A visual inspection was performed and noted there was continuous peeling on markers of the insertion tube and the scope produced a blurry image. Additionally, the bending section cover adhesive at the distal area was cracked and peeling. A review of the scope's repair history indicates the scope was purchased on (b)(6) 2008 with two service/repairs in the last four years. The last repair (major repair) was performed on october 11, 2018. The scope was repaired and returned to the user facility. The investigation is ongoing. However, if additional information becomes available this report will be supplemented accordingly. Chapter 2 in the instruction for use (ifu) indicates the eto cap must be installed prior to eto gas sterilization and aeration and removed prior to immersion or clinical examination. The cap must also be attached when the endoscope is transported outside the hospital (shipment, return for repairs, etc. ).

 
Event Description

The service center was informed by the onsite support specialist that the user facility's cysto-nephro fiberscope was incorrectly reprocessed as the scope was reprocessed without the vent cap. There was no patient involvement reported.

 
Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-05104. The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted. An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode. The root cause has been determined to be due to incorrect reprocessing processing (no patient involvement) / failure to follow the instructions for use (ifu). Chapter 2 in ifu indicates the eto cap must be installed prior to eto gas sterilization and aeration and removed prior to immersion or clinical examination. The cap must also be attached when the endoscope is transported outside the hospital (shipment, return for repairs, etc. ). Olympus 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 Key10353214
MDR Text Key223662246
Report Number8010047-2020-05104
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
Report Date 11/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2020
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 Manufacturer07/08/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/04/2008
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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