• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VH
Device Problem Microbial Contamination of Device (2303)
Patient Problem Sepsis (2067)
Event Date 10/01/2016
Event Type  Injury  
Manufacturer Narrative

After the subject device was reprocessed at the olympus (b)(4), the subject device was returned to olympus (b)(4) for evaluation. It was confirmed that some scratches were found on the light guide lens, and wear and tear on the bending rubber of the subject device. As a result of the culture test on the subject device that (b)(4) ordered an independent laboratory, no microorganism was detected. An olympus service representative observed the user facility¿s reprocessing procedure with no reprocessing deviations noted the exact cause could not be determined at present. If significant additional information is received later, a supplemental report will be submitted. This is report 3 of 5.

 
Event Description

Olympus medical systems corp. (omsc) was informed that five patients were admitted with urosepsis after having undergone the procedure by the subject device. Pseudomonas was detected in two patients of the five. It is unknown whether the bacteria were detected in the remaining three patients of the five. As a result of the culture test on the subject device performed by the facility, pseudomonas was detected from the instrument channel of the subject device.

 
Manufacturer Narrative

Olympus (b)(4) reported on december 5, 2016 that microorganisms were detected from a 3 way-tap and no microorganism was detected from the subject device. Olympus medical systems corp (omsc) will collect information of the 3-way tap. If significant additional information is received at a later time, a supplemental report will be followed.

 
Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo-to 
8142642517
MDR Report Key6134092
MDR Text Key61086622
Report Number8010047-2016-10076
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
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 Received02/13/2019
Was Device Evaluated By Manufacturer? No
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: 11/29/2016 Patient Sequence Number: 1
-
-