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

MAUDE Adverse Event Report: OLYMPUS AMERICA INC OLYMPUS CYSTOSCOPE URF - P6R

  • 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 AMERICA INC OLYMPUS CYSTOSCOPE URF - P6R Back to Search Results
Model Number URF-P6R
Device Problem Insufficient Information (3190)
Patient Problem Perforation (2001)
Event Date 11/14/2018
Event Type  Injury  
Event Description

Physician was performing a cystoscopy, left ureteroscopy, laser lithotripsy for 4 hours more. When the scope was removed, there was stone and part of the ureter on the cystoscope. Pt had to have an add'l stent placed, left nephrostomy tube placed and a foley catheter placed. Some of the staff reported seeing sparks related to the laser on the screen. I am still interviewing staff and looking for info on the disposable fiber optic. The investigation does not indicate whether or not this event is operator error or equipment malfunction.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOLYMPUS CYSTOSCOPE URF - P6R
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS AMERICA INC
3500 corporate pkwy
center valley PA 18034
MDR Report Key8142523
MDR Text Key129760964
Report Number8142523
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberURF-P6R
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/16/2018
Device Age18 mo
Event Location Hospital
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/06/2018 Patient Sequence Number: 1
-
-