MAUDE Adverse Event Report: Merit Medical Systems Inc. SCOUT MD¿; MARKER, RADIOGRAPHIC, IMPLANTABLE

Catalog Number	MDS75C-01
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the patient came in for preoperative localization with savi scout md radar reflector.The first reflector was self-deployed, so an additional second radar reflector was implanted at the site by the physician.The patient was made aware that two devices had been implanted.Following discussion with physician, the patient will undergo surgery and the surgeon will determine whether one or both will be removed.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.

• Brand Name: SCOUT MD¿
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• 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: 50896224
• Report Number: 1721504-2026-00443
• Device Sequence Number: 6001498
• Product Code: NEU
• UDI-Device Identifier: 00884450392959
• UDI-Public: 00884450392959
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: MDS75C-01
• Device Lot Number: H3507787
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown