MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SCOUT®; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	M
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was having a savi reflector placed to be removed in breast surgery- davi was placed in the breast but when checked with the savi detector, the savi would not register.A second savi device was placed in the breast and checked with the savi detector and a signal was immediately received.

• Brand Name: SCOUT®
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 24799446
• Report Number: 24799446
• Device Sequence Number: 10707461
• Product Code: NEU
• UDI-Device Identifier: 00884450582848
• UDI-Public: (01)00884450582848(17)290105(10)H3434397
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026
• Report Date (Section F): 03/31/2026

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 Model Number: M
• Device Catalogue Number: SSR75S-01
• Device Lot Number: H3434397
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 03/31/2026