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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-V2R
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 01/08/2019
Event Type  Injury  
Manufacturer Narrative

Insufficient information regarding the reported event was provided by the user facility. Multiple follow ups were made via telephone and in writing but no information has been obtained. The scope was returned to olympus but the evaluation is in progress. As part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training. To date, the ess visit has not been finalized. The cause of the reported event cannot be confirmed. However, if additional information becomes available this report will be supplemented accordingly.

 
Event Description

Olympus was informed that a patient tested (b)(6) for an unspecified infection after undergoing a procedure. The patient reportedly came in with a fever. The scope was then tested and cultured (b)(6) for an unspecified organism after reprocessing.

 
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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
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8313576
MDR Text Key135342542
Report Number2951238-2019-00419
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberCYF-V2R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/28/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/03/2019
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

Patient TREATMENT DATA
Date Received: 02/06/2019 Patient Sequence Number: 1
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