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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The damaged device has not been returned to olympus for repair and evaluation. Based on the information provided to olympus by the user facility, the cause of the damage to the scope has been assigned to the user due to failure to follow the instructions for use reprocessing instructions. The user facility stated the cap was not attached during sterilization. A sterilizer (unknown manufacturer, model and serial number) is being used to reprocess the endoscopes. The instructions for use provides the following caution statement when performing sterilization: "caution: attach the eto cap to the venting connector before sterilization. If the eto cap is not attached to the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section. ".

 
Event Description

A user facility reported to olympus that their videoscope was damaged due to incorrect reprocessing. The reported damage was described as "the insulation goes past the distal tip. " the issue was found on inspection during preparation for a procedure. The type of intended procedure is unknown. It is unknown if the intended procedure was completed. There was no patient injury associated with the problem reported to olympus. Per the user facility, the incorrect processing was due to a new person in the reprocessing area and the individual was not aware of the correct scope reprocessing procedures. The scope was not cultured. No patient impact associated with the incorrect reprocessing and scope damage was reported to olympus. The user facility stated that the damage was limited to 1 scope.

 
Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer device history record (dhr) review. Upon review of the dhr for the involved device, it was confirmed that there were no abnormalities, special adoptions, or variations in the manufacturing process.

 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
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 Key10006364
MDR Text Key222560497
Report Number8010047-2020-02409
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/05/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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