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

Model Number	CA30L1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
The customer reported that during a workshop in (b)(4) (covidien distributor) the unit interrupted the water flow shortly after the beginning of the ablation on the bovine liver.

• Brand Name: 30CM PERCUTANEOUS ANTENNA X1
• Common Device Name: ABLATION ANTENNA
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); 10 bldg, no.789 puxing rd; shanghai ; CH
• MDR Report Key: 5387632
• Report Number: 3006451981-2016-00077
• Device Sequence Number: 13492060
• Product Code: NEY
• UDI-Device Identifier: 10884521189553
• UDI-Public: 01108845211895531716051610S4EG004X
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/20/2016

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: 05/31/2019
• Device Model Number: CA30L1
• Device Catalogue Number: CA30L1
• Device Lot Number: S4EG004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1