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U.S. Department of Health and Human Services

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

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MERIT MEDICAL SYSTEMS, INC. TEMNO EVOLUTION BIOPSY NEEDLE Back to Search Results
Model Number CTT2011
Device Problems Output Problem (3005); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 04/11/2022
Event Type  malfunction  
Event Description
While testing the temno evolution (20g x 11cm) before using on the patient and it was noticed that the device was sticking and not working properly.
 
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Brand NameTEMNO EVOLUTION
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 west merit parkway
south jordan UT 84095
MDR Report Key14250188
MDR Text Key290382540
Report Number14250188
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 Other Health Care Professional
Type of Report Initial
Report Date 04/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCTT2011
Device Catalogue NumberCTT2011/B
Device Lot NumberI2233520
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2022
Event Location Hospital
Date Report to Manufacturer04/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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