MAUDE Adverse Event Report: COVIDIEN LLC (SHANGHAI) 30CM PERCUTANEOUS ANTENNA X1; ABLATION ANTENNA

Model Number	CA30L1
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The return of the incident sample has been requested.To date, it has not been received for evaluation.Additional questions in regard to the incident have been asked.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported that during a surgical liver ablation procedure, the pump was activated but the water flow was disturbed.When the generator was activated there was a temperature alert and the antenna wouldn't work.Another antenna was used.
Additional Manufacturer Narrative
Covidien reference#: (b)(4).Date of initial report: 01/29/2016.Date of follow-up report: 02/18/2016.Evaluation of the incident antenna confirmed the reported failure.Covidien¿s investigation identified two possible root causes for the device failure.The hub divider shifting distally within the hub or the inflow tube expanding or rupturing.Corrective actions have been implemented.A spacer was added to prevent the hub from shifting.Additionally, the inflow tube material was revised.The new inflow tube is made from polyimide, which results in inflow tubes with more strength reducing the likelihood of expansion or rupture.

• Brand Name: 30CM PERCUTANEOUS ANTENNA X1
• Common Device Name: ABLATION ANTENNA
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); 10 bldg, no.789 puxing rd; shanghai 20111 4; CH 201114
• MDR Report Key: 5398467
• Report Number: 3006451981-2016-00092
• Device Sequence Number: 928217
• Product Code: NEY
• UDI-Device Identifier: 10884521189553
• UDI-Public: 01108845211895531716101610S4KG004X
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Followup
• Report Date (Section B): 01/04/2016

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: 10/31/2019
• Device Model Number: CA30L1
• Device Catalogue Number: CA30L1
• Device Lot Number: S4KG004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2016
• Supplement Report FDA Received Date: 02/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR