MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-ECLIPSE® ELECTRODE; ELECTRODE, NEEDLE

Model Number	NRE1003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No analysis was performed as the device has not been returned at this time.A follow up report will be submitted if the device or component is returned at a later date.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional reported via a manufacturer representative that the patient suffered a third degree burn on the right iliac crest at the location of the grounded plate.Medical history of the patient included penicillin allergy, and no smoking, alcohol, or drugs.It was noted that the device was discarded by the customer.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the manufacturer representative indicated that the burn was around five square centimeters.They didn't know what was done to treat the burn or if the patient recovered without sequela.The burn was discovered after the surgery in the patient room.They didn't know if electrosurgical equipment was being used.The components of the system were put in the rubbish and the nurse wasn't sure about the serial number of the equipment.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the health care provider (hcp) reported via a manufacturer representative that an electrosurgical equipment was used during the surgery but it was not known whether it was in use when the burn occurred since the burn was under the blanket and not close to the field of operation, therefore the surgeon only noticed the burn after the surgery.Cream, pansement, bandage were used to treat the burn.The patient have a scar from the burn.

• Brand Name: NIM-ECLIPSE® ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7776884
• Report Number: 1045254-2018-00365
• Device Sequence Number: 1319380
• Product Code: GXZ
• UDI-Device Identifier: 00613994871497
• UDI-Public: 00613994871497
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: NRE1003
• Device Catalogue Number: NRE1003
• Device Lot Number: 170731002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 06/11/2019
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/17/2018; 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 61