MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EVIDENT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VT2237
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intraoperatively, the antenna tip broke when the physician inserted it in the liver.All antenna parts were completely removed from the patient¿s body.A new antenna was needed in order to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Additional: evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the antenna was broken at the plastic feed point.The broken section was still attached.The investigation found that the plastic feed point in the radiating section was fractured.The inner conductor wire is still intact.The investigation identified the root cause of the reported event to be user error.The instructions for use (ifu) states: do not apply excessive lateral or rotational force during the insertion or extraction of the antenna.Doing so may lead to breakage at the antenna feed point and injury to the patient or user.Use a scalpel or electrosurgical pencil to expand the insertion point if you meet resistance.Although the antenna is slightly flexible, using force may lead to breakage at the antenna feed point and possible injury to the patient.Do not attempt to bend or reshape antennas.Product damage and/or malfunction may result.View the inserted portion of the antenna using image guidance, such as computerized tomography (ct) or ultrasound, to ensure the antenna is not bent or broken.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVIDENT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7447178
• Report Number: 1717344-2018-00526
• Device Sequence Number: 14006028
• Product Code: GEI
• UDI-Device Identifier: 10884524000688
• UDI-Public: 10884524000688
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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: 05/29/2022
• Device Model Number: VT2237
• Device Catalogue Number: VT2237
• Device Lot Number: 71500071X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR