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

Model Number	PS210-030S
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Codes	Numbness (2415); Electric Shock (2554)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via manufacture representative (rep) regarding a generator and a handpiece.It was reported that during a battery replacement, the patient experienced one big electrical shock that went to the opposite right arm and hand and also to upper leg and lower leg.Not the foot at all.It was noted that the patient did feel numbness in the right arm and leg for 5 minutes.It went away after 10 minutes totally.It was further stated that the handpiece tip did touch accidently the implantable neurostimulator when the neurosurgeon was dissecting in the upper part of the pocket.The neurosurgeon did stop to use the generator and the handpiece immediately.The doctor did measure post-operative electrode impedance and therapy impedance.They were all with in the same range as before the battery replacement.There was no reported impact to patient outcome.

• Brand Name: PLASMABLADE 3.0S
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11563570
• Report Number: 1226420-2021-00068
• Device Sequence Number: 4781149
• Product Code: GEI
• UDI-Device Identifier: 00643169617148
• UDI-Public: 00643169617148
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K093695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 04/12/2023
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 0219844367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/24/2021
• 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