MAUDE Adverse Event Report: RF SURGICAL SYSTEMS INC. MEDTRONIC SITUATE; RAYTEC GAUZE

Model Number G0404-16P01C-1

Device Problem Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/05/2017

Event Type  Injury  

Event Description

The rfid device on a raytec separated from the raytec.The soft count was correct but when the patient was scanned it was found that one of the raytec had the rf id missing.The patient was still in the operating suite and the surgeon was called back to find the rf id which was noted to be adhered to the bowel.

• Brand Name: MEDTRONIC SITUATE
• Type of Device: RAYTEC GAUZE
• Manufacturer (Section D): RF SURGICAL SYSTEMS INC.; carlsbad CA
• MDR Report Key: 6895082
• MDR Text Key: 87587063
• Report Number: 6895082
• Device Sequence Number: 1
• Product Code: GDY
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G0404-16P01C-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 67