MAUDE Adverse Event Report: CP MEDICAL, INC. FIDUCIAL MARKER; ACCELERATOR, LINEAR, MEDICAL

Model Number FNS1812-1

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Event Description

While placing fiducial markers in liver, two packages were opened both with same labeling.One device was 20cm instead of the labeled 12cm.Fiducial markers were placed without incident or harm to the patient.

• Brand Name: FIDUCIAL MARKER
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): CP MEDICAL, INC.; 1775 corporate dr ste 150; norcross GA 30093
• MDR Report Key: 7094921
• MDR Text Key: 94110015
• Report Number: 7094921
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Model Number: FNS1812-1
• Device Catalogue Number: FNS1812-1
• Device Lot Number: 160802-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2017
• Event Location: Other
• Date Report to Manufacturer: 11/29/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR