MAUDE Adverse Event Report: BSD MEDICAL CORP. MICROTHERMX SYNCHOWAVE ST; SHORT TIP MICROWAVE ANTENNA KIT

Model Number REF SWST-1415

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Information (3190)

Event Date 11/13/2014

Event Type  Injury  

Event Description

After patient underwent microwave ablation, surgeon removed microwave needles, only to find that one was shorter than the other.Ct scan found subcutaneous right chest wall needle tip.Patient taken to ultrasound for tip retrieval.

• Brand Name: MICROTHERMX SYNCHOWAVE ST
• Type of Device: SHORT TIP MICROWAVE ANTENNA KIT
• Manufacturer (Section D): BSD MEDICAL CORP.; 2188 w. 2200 s.; salt lake city UT 84119
• MDR Report Key: 4297531
• MDR Text Key: 5269198
• Report Number: 4297531
• Device Sequence Number: 1
• Product Code: NEY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: REF SWST-1415
• Device Catalogue Number: 15 CM, SHORT TIP
• Device Lot Number: 131075
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2014
• Distributor Facility Aware Date: 11/13/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROTHERMX MICROWAVE ABLATION GENERATOR; S/W REV 2.2.2.1; MODEL: MTX-180-T2, SERIAL # (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR