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

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO EVOLUTION® BIOPSY NEEDLE

  • 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
 

MERIT MEDICAL SYSTEMS, INC. TEMNO EVOLUTION® BIOPSY NEEDLE Back to Search Results
Model Number 10884450443405
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2022
Event Type  malfunction  
Event Description
An elderly male in the ct scan diagnostic imaging for percutaneous lymph node biopsy. No patient involvement as device was not introduced into patient. Device-related only, this patient was not affected as the device was tested first to be sure the lid/cap of the introducer would be able to be removed from the introducer as recently there have "been a few" instances whereby the introducer is deployed, and when ready to add the biopsy needle into the introducer the cap would not release and then the procedure would have to be redone (first introducer withdrawn, another kit opened and then the new introducer utilized). Our work around/temporary process is to be sure the lid is not adhered to the introducer. In this particular case, no delay in process but a second biopsy device was required and in the past each case apparently utilized more than one due to this now-revealed issue. We do not have an accurate count of previous issues but moving forward the team will not only make note but also secure the device information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTEMNO EVOLUTION®
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 west merit parkway
south jordan UT 84095
MDR Report Key14280116
MDR Text Key290682707
Report Number14280116
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10884450443405
Device Catalogue NumberCTT1820/B
Device Lot Number12217644
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2022
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer05/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-