MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. TEMNO ELITE¿; SOFT-TISSUE BIOPSY PROCEDURE KIT

Catalog Number	TEVC2015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted when the evaluation is complete.
Event or Problem Description
It was reported that during a ct lung biopsy procedure, the needle of the biopsy device broke off inside the patient.A new device was used to complete the procedure.No additional available.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The failure reported by the customer was observed.The root cause being attributable to the equipment used during bonding of these parts.It is likely during manufacturing this particular unit did not have sufficient adhesive applied 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.Nonconformances of this nature are monitored by the operation team.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TEMNO ELITE¿
• Common Device Name: SOFT-TISSUE BIOPSY PROCEDURE KIT
• 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: 24957041
• Report Number: 1721504-2026-00023
• Device Sequence Number: 10048184
• Product Code: KNW
• UDI-Device Identifier: 00884450397763
• UDI-Public: 00884450397763
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/15/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: TEVC2015
• Device Lot Number: H3343575
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: Not provided; 05/15/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/05/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown