MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE 3.0S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PS210-030S

Device Problems Fire (1245); Melted (1385)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

Complaint confirmed: upon receiving the device, there was a deformation on the back of the device that the complaint was about.The silicone was peeled back, and the device was opened to investigate into the assembly of the device.Upon opening the device, with observation, the wires were pinched and exposed which contributed to the malfunction of the device during the usage of the device.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a generator and a handpiece.It was reported that during a case, the surgeon stated he felt an electrical pulse sting when he was pressing the coagulation button.Later on, in the case, he was pressing coagulation button again and felt the electric pulse again, on his long finger.Handpiece burned his finger.There was no permanent impairment to the doctor and intervention was not necessary.The handpiece was flipped over and a burn mark was discovered on the green portion of the handpiece.Additionally, it was stated that the rep noticed that the hose was not connected to the device, appeared to have been pulled out of the handpiece.There was a reported delay of less than one hour and no impact to patient outcome.

• Brand Name: PLASMABLADE 3.0S
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10377576
• MDR Text Key: 201988554
• Report Number: 1226420-2020-00082
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00763000059811
• UDI-Public: 00763000059811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 2001133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• 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