MAUDE Adverse Event Report: Merit Medical Systems Inc. TEMNO Elite¿; INSTRUMENT, BIOPSY

Catalog Number	TEC1815
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction

• 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
• MDR Report Key: 50927800
• Report Number: 1721504-2026-00458
• Device Sequence Number: 10725289
• Product Code: KNW
• UDI-Device Identifier: 00884450397619
• UDI-Public: 00884450397619
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K201166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: TEC1815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown