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

Model Number	00884450433959
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We had an issue where the handpiece was acting funny and was saying no connection and then it would be ready then you would have to press the start button multiple times during the procedure.We could not determine at that time if it was the base or the hand piece.Another hand piece was obtained that matches the same lot # and expiration date and item #.Turned the machine off to allow it to rest, came back and turned the machine back on, plugged the new hand piece in that we were prepared to waste to test it with it never produced an issue.Plugged the fieldpiece in again after a few minutes it did give us warning.Unplugged it and plugged the new handpiece in again just to verify, no issues unplugged it one last time, and we still got an issue with a handpiece that was in the field.We are saying at this point, it is the handpiece, and not the cord that's attached that's disposable and not the machine.

• 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: 19114959
• Report Number: 19114959
• Device Sequence Number: 12538366
• Product Code: NEU
• UDI-Device Identifier: 00884450433959
• UDI-Public: (01)00884450433959(11)230522(10)H2675112
• 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): 01/23/2024
• Report Date (Section F): 01/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 00884450433959
• Device Catalogue Number: HPSU-01/B
• Device Lot Number: H2675112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Date Report Sent to FDA: 01/23/2024