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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
Lot Number I2076202
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Event Description
After the first biopsy pass with temno needle, the cutting portion of the needle did not retract so the initial biopsy specimen could not be retrieved. Another needle was retrieved, and the tissue obtained on the first pass needed to be discarded along with the needle.
 
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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 Key11854645
MDR Text Key251692974
Report Number11854645
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
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberI2076202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/18/2021
Event Location Hospital
Date Report to Manufacturer05/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/20/2021 Patient Sequence Number: 1
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