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

Model Number DME1004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported via manufacturer representative that under the ground plate of the device the patient was burned.Patient was alive-with injury.Additional information received from the hcp stating that nobody knows the sequence of events when the burn was discovered because it was discovered after surgery when they took off the operating field.And the sequence of events during the surgery was classical ¿scoliosis¿ spine surgery.The surgery procedure included an electrosurgical dissection as it is usual during the dissection.The burn was under a ground plate, the green one.The ground pad of electrosurgical was on the other side of the patient on the hip.There were no electrode wires and power cords, crossing when the incident occurred.It was a 2nd degree burn and they provided vitamin a cream for treatment.The patient is currently good.

• Brand Name: NIM-ECLIPSE® ELECTRODE
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9284773
• MDR Text Key: 165255527
• Report Number: 1045254-2019-00557
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

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
• Device Operator: Health Professional
• Device Model Number: DME1004
• Device Catalogue Number: DME1004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other