MAUDE Adverse Event Report: COVIDIEN LLC (SHANGHAI) 20CM PERCUTANEOUS ANTENNA X1; ABALTION ANTENNA

Model Number	CA20L1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien reference#: (b)(4).Date of initial report: 03/17/2016.Evaluation of the incident antenna confirmed it was broken.The break is consistent with the antenna exceeding the shaft bend radius limit.Review of the manufacturing records for the reported lot number confirmed the lot was released meeting all specifications.No trend has been identified for this failure mode.
Event or Problem Description
The customer reported that the device was being positioned within a lesion which the surgeon wished to thermally ablate and the device snapped at the junction of the shaft and the antenna handle.The device was removed without activation.The antenna broke during placement but did not separate until after it was removed from the patient.The patient was large (high bmi) and required a longer probe to access the liver lesion.There was no injury to the patient.No medical intervention was required.They used another probe to correct the problem and it worked without further consequence.

• Brand Name: 20CM PERCUTANEOUS ANTENNA X1
• Common Device Name: ABALTION ANTENNA
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); 10 bldg, no.789 puxing rd; shanghai 20111 4; CH 201114
• MDR Report Key: 5508653
• Report Number: 3006451981-2016-00161
• Device Sequence Number: 11046540
• Product Code: NEY
• UDI-Device Identifier: 10884521189546
• UDI-Public: 01108845211895461717010710S5AG002X
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: CA20L1
• Device Catalogue Number: CA20L1
• Device Lot Number: S5AG002X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2016
• Initial Report FDA Received Date: 03/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1