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

Model Number SG-01/A SCOUT GUIDANCE HANDPIECE

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

Savi scout probe used took 3 attempts to remove radioactive chip, additional breast tissues was remove.Fda safety report id# (b)(4).

• Brand Name: SAVI SCOUT
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. ; south jordan UT 84095
• MDR Report Key: 11588441
• MDR Text Key: 243141268
• Report Number: MW5100357
• Device Sequence Number: 1
• Product Code: NEU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SG-01/A SCOUT GUIDANCE HANDPIECE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1