MAUDE Adverse Event Report: Merit Medical Systems, Inc. TEMNO Elite¿; Instrument, Biopsy

Catalog Number	TEVC1815
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During malignant lymphoma biopsy of a hard retroperitoneal tissue after one successfull firing, during second firing, the patient complained of pain.When the needle was withdrawn from the body, the needle tip was missing and had remained inside the patient.The fractured needle tip was subsequently retrieved via open surgery.
Additional Manufacturer Narrative
The suspected device was received.The investigation is ongoing.If additional reportable information becomes available, it will be submitted in a supplemental report.

• 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: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50010285
• Report Number: 1721504-2026-00515
• Device Sequence Number: 8385264
• Product Code: KNW
• UDI-Device Identifier: 00884450397725
• UDI-Public: 00884450397725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: TEVC1815
• Device Lot Number: H3298212
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown