Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-P6R
Device Problem Problem with Sterilization (1596)
Patient Problem Hepatitis (1897)
Event Type  Injury  
Event Description
A study coordinator (physician) reported, after an ureteroscopy using a urf reusable ureteroscope (exact model and serial number not provided).A patient contracted (b)(6).The physician suggests insufficient sterilization prior to using the reusable ureteroscope as the possible cause.No additional consequences to the patient were reported.It is not known what interventions /treatment the patient received as a result.The patient's current condition is unknown.No further information can be requested.The reported stated they did not want to be contacted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
URETERO-RENO FIBERSCOPE
Type of Device
URETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key13892057
MDR Text Key288127839
Report Number2951238-2022-00361
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340833
UDI-Public04953170340833
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/03/2022,03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-P6R
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/03/2022
Event Location Hospital
Date Report to Manufacturer03/03/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/24/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-