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

Model Number	VT1737
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
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, during ablation, the device broke when placing it on the ribs.New device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Investigation summary one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the antenna was broken at the plastic feed point.The customer reported that the device broke when placing it on the ribs.The reported condition was confirmed.The investigation found that the plastic feedpoint 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 instruction for use states: do not apply excessive lateral or rotational force during insertion or extraction of the antenna.Doing so may lead to breakage at the antenna feedpoint 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 feedpoint 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 ct or ultrasound, to ensure the antenna is not bent or broken.No update to the risk management file is required at this time.Manufacturing non-conformance were reviewed.No entries pertinent to the customer's report were noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during ablation, the device broke when placing it on the ribs; however, the doctor was able to retract the antennas without damage.No part of the antenna came loose; it just fell over and the antenna was salvaged successfully.New device was used to complete the case.There was no patient injury.

• 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: 7300757
• Report Number: 1717344-2018-00276
• Device Sequence Number: 1823462
• Product Code: GEI
• UDI-Device Identifier: 10884524000671
• UDI-Public: 10884524000671
• 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): 03/22/2018

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: 12/20/2021
• Device Model Number: VT1737
• Device Catalogue Number: VT1737
• Device Lot Number: 63560164X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1