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

Catalog Number	TE1820
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that while the physician was taking a biopsy, the needle split into pieces.The physician's assistant pricked themselves on the needle requiring minor first aid.
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 medical device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.Should the device be returned later, the investigation will be reopened.

• 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: 22097338
• Report Number: 1721504-2025-00078
• Device Sequence Number: 20917785
• Product Code: KNW
• UDI-Device Identifier: 00884450397879
• UDI-Public: 00884450397879
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: TE1820
• Device Lot Number: H2890942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown