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

Model Number	E7506-
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample was requested but the customer has indicated that the device is not available for return.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported that a patient burn occurred during an ablation procedure where this device was used.The procedure was performed to treat a 4.5cm kidney tumor, and involved a 3.5cm leveen as well as a boston scientific rf3000 generator, s/n (b)(4).The generator was used for 4x15 minutes at 180 watts, and the needle was repositioned several times.When four electrodes were removed, a 2b to 3rd degree burn was found under a pad on the thigh.The burn was 2cmx10cm.The patient had been sweating during the ablation.The patient was transferred for treatment of the burns, including surgery as well as "abradement" of necrotic tissue.At the time of this report, the patient was still receiving treatment within the hospital.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6969181
• Report Number: 1717344-2017-06087
• Device Sequence Number: 13681176
• Product Code: GEI
• UDI-Device Identifier: 20884524000982
• UDI-Public: 20884524000982
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K822572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: E7506-
• Device Catalogue Number: E7506-
• Device Lot Number: 60550066X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC RF3000 GENERATOR (SN (B)(4))
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR