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: COOK IRELAND LTD RESONANCE STENT SET
  • 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
 

COOK IRELAND LTD RESONANCE STENT SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Break (1069)
Patient Problems Perforation (2001); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Common device name: fad stent, ureteral.
 
Event Description
According to the initial reporter, it (stent) was only mildly encrusted but i think the primary issue was the proximal tail being stuck in tight infundibulum and i could not extract it the first time around (it torn down into a wire which i cut and left in situ the firs time around).After using the flex-xs2 and opening the infundibulum up with a laser i was able to manually retract it down.I¿m glad this worked as the next step was some type of open/robotic procedure which would have been much more morbid.Per physician - no other adverse issue though patient is prone to uti and felt unwell after first procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESONANCE STENT SET
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key14451315
MDR Text Key292186564
Report Number3005580113-2022-00058
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2022
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 Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/19/2022
Distributor Facility Aware Date04/22/2022
Event Location Hospital
Date Report to Manufacturer05/19/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-