MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. TEMNO ELITE¿; INSTRUMENT, BIOPSY

Catalog Number	TEVC2015
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the biopsy needle did not fitting properly in the coaxial introducer.A new device was used to complete the procedure.No patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.Resistance appears to occur when the echogenic bumps on the biopsy needle reach the coaxial hub.These laser marks can occasionally cause slight protrusions, which may interfere with smooth insertion and contribute to the resistance experienced.A search of the complaint database was performed and one similar complaint for this lot number were found.The device history record was reviewed, and no exception documents were found.Corrective actions are taken as warranted.Trend data will be used to monitor complaints and the performance of production processes and quickly address any deviations from established standards.

• Brand Name: TEMNO ELITE¿
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22660709
• Report Number: 1721504-2025-00194
• Device Sequence Number: 7495833
• Product Code: KNW
• UDI-Device Identifier: 00884450397770
• UDI-Public: 00884450397770
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K201166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: TEVC2015
• Device Lot Number: H2997827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown