• 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 Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2020
Event Type  Malfunction  
Manufacturer Narrative

This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic. Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity. The facility uses ecolab pureclean neutral detergent to manually clean the devices. They also use schulke thermosept detergent for automated endoscope reprocessing machine distributed by cantell. The devices were returned to olympus. Olympus tested them at a laboratory. The results reported that the devices tested negative for microorganisms and the black foreign materials derived from rubber , but not from microorganisms. The laboratory also reported that chemicals used for endoscope reprocess could produce the black substances. The devices were then returned to the customer after repair. Olympus performed on-site investigation and found that some components coming from rubber and copper were detected in the facility's sink used for the endoscope reprocessing. The exact cause of the reported event could not be conclusively determined. However, based on the information above, sterilizing the endoscopes with rubber and copper adhered to the distal end was likely to produce the black substances. In order to address the issue, the customer will check if no foreign materials adhere to the surface of the devices and make sure that the devices are completely dry. If additional information becomes available, this report will be supplemented.

 
Event Description

The customer repeatedly experienced that black foreign materials adhered to the distal end of their nine cyf-vhs. There was no report of infection associated with this report. A total of nine mdrs are being submitted for the nine endoscopes. This is the fifth one of the nine reports.

 
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 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 Key10646394
MDR Text Key224676271
Report Number8010047-2020-07350
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/27/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-