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

Catalog Number	TEC1810
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	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that the biopsy needle did not fitting properly in the coaxial introducer.No patient injury.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation the internal diameter (id) of the introducer/coaxial was within specifications.Resistance appears to occur when the echogenic bumps of 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.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were found.Non-conformances of this nature are monitored by the engineering, quality and management team members.

• 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: 22660652
• Report Number: 1721504-2025-00185
• Device Sequence Number: 7449283
• Product Code: KNW
• UDI-Device Identifier: 00884450397602
• UDI-Public: 00884450397602
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: TEC1810
• Device Lot Number: H3136373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown