• 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. URETERO-RENO FIBERSCOPE

  • 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. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P7
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2022
Event Type  malfunction  
Manufacturer Narrative
The olympus scope was sent to an independent laboratory for culture testing. All channels were sampled. The device tested positive for less than one (1) colony forming unit of unspecified micro-organisms. The obtained results are in conformance with the requirements. The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes. During pre-cleaning, the customer uses detergent onelife enzimed prevent, suctions water out of the channels and flushes out the air/water, auxiliary washing, balloon and the forceps elevator channel. During manual cleaning, the customer brushes the operating channel, the suction pistons/cylinders, the operating channel port, balloon channel and the distal end/area around the forceps elevator. The customer manually disinfects the scopes using anioxyde 1000. The scope was stored in a cabinet without a drying cabinet and olympus is the customer¿s maintenance company. The scope was not sterilized. The device has been returned to olympus for evaluation. The evaluation is currently in process. The investigation is ongoing. A supplemental report will be submitted upon completion of the investigation.
 
Event Description
The customer reported to olympus, the uretero-reno fiberscope tested positive for one (1) colony forming unit (cfu) of bacillus species. All channels were sampled. The issue was found during a routine culture of the scope. Sampling was taken at reprocessing, before use. The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation. A review of the device history record found no deviations that could have caused or contributed to the reported issue. Based on the results of the investigation, a root cause could not be determined. Growth of microorganisms were found through culture testing by the user after reprocessing. However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation. The following is included in the device ifu: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them. " olympus will continue to monitor field performance for this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
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 Key13472057
MDR Text Key296237692
Report Number8010047-2022-02485
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403811
UDI-Public04953170403811
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-