• 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 Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Event Description
The customer reported that during reprocessing foreign material exiting the scope¿s channel. The customer observed bioburden in the channel. There were no associated patient infections.
 
Manufacturer Narrative
The scope was returned to the service center for evaluation. The customer¿s complaint of ¿bioburden/foreign material in the scope channel¿ was not confirmed. An olympus borescope was used to inspect the scope¿s channel and no foreign material or bioburden were observed. No abnormalities were noted on the scope. As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary. To date, the ess visit has not been finalized. An investigation is ongoing to obtain additional information regarding the reported event. If additional information is received this report will be supplemented accordingly.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation. The subject device was refurbished and as per device inspection result after refurbishment, the quality of the subject device was satisfactory. Olympus only releases products to market that meet all manufacturing specifications and final product release criteria. The case is not due to design. Based on the results of the investigation, and while the phenomenon was not reproduced, it is likely that foreign material temporarily remained in channel due to inappropriate reprocessing after previous procedure. A definitive root cause cannot be identified. Users can detect the suggested event properly by handling the device in accordance with the following instructions for use (ifu). "operation manual_ inspection of the endoscopic system_ inspection of the instrument channel" users can reduce/prevent the suggested event by handling the device in accordance with the following ifu. "reprocessing manual_ precleaning the endoscope_ flush the instrument channel with water manually cleaning the endoscope_ brush the channel" olympus will continue to monitor the field performance of 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 Key13233221
MDR Text Key293267875
Report Number8010047-2022-01276
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2022
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 Manufacturer12/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/03/2022
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

-
-