MAUDE Adverse Event Report: CARE WISE MEDICAL PRODUCTS CORP / SOUTHERN SCIENTIFIC LTD. C-TRAK GALAXY SYSTEM GAMMA RAY DETECTOR; PROBE, UPTAKE, NUCLEAR

Model Number CW 4000

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

Defective system is used to detect gamma rays to identify sentinel nodes.Device failed/malfunctioned manufacturer notified, sent out for repair.Returned '5/4' with many internal failures noted by manufacturer that were rectified.Fda safety report id# (b)(4).

• Brand Name: C-TRAK GALAXY SYSTEM GAMMA RAY DETECTOR
• Type of Device: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): CARE WISE MEDICAL PRODUCTS CORP / SOUTHERN SCIENTIFIC LTD.
• MDR Report Key: 14488208
• MDR Text Key: 292613623
• Report Number: MW5109843
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• 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: 05/19/2022

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 Operator: Health Professional
• Device Model Number: CW 4000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1