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

Model Number PS210-030S

Device Problem Arcing of Electrodes (2289)

Patient Problems Muscle Spasm(s) (1966); Muscular Tics (2161); Dysphasia (2195); Electric Shock (2554)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) regarding a generator and handpiece.It was reported that the generator was turned on and self-check was normal.The handpiece was attached to the generator.The smoke evacuator activator was put very close on the handle contact.The settings were put to cut 5 and coag 6.Upon activation of the handle coag, the generator alarm went on with a red light square and alarm noise due to lack of patient return electrode.A patient return electrode was attached on the patients right upper thigh top.Green light (square) turned up.The hcp activated the coag again and performed coagulation and then cut to dissect their way down to the dbs-battery capsula/battery pocket.The dbs-battery pocket was closed by the last layer of fibrotic tissue when the event occurred.The hcp was using the handle cut 5 when trying to dissect the last layer of the fibrotic capula around an almost totally depleted internal neurostimulator.Suddenly the patient received a heavy electrical shock on the right part of the body, with heavy muscle contractions from head to all 5 toes.Heavy symptoms of muscular contractions on right side of the body were reported from head, face, neck, shoulder, arm, hand, 5 fingers, hip, leg and all 5 toes, because of the electrical shock.In face there was a heavy contraction of right corner of the mouth and cheek.No lightning arc was visible.But the electrical shock was very visible to everyone at the or-room and the awake patient.The patient lost the possibility to talk normally for approximately 4-5 minutes after the event.The hcp opened up the fibrotic pocket with a scissor, detached the old ins and replaced it with a new ins.The new ins was put down into the pocket and the dbs-stimulation initiated.No alarms was heard and no alarms were visible at the generator or the rapidvac smoke evacuator when the event did happened or afterwards.The hcp did not use the handpiece any more and was asking the or-staff to remove it from the surgical field.The patient was double checked with dbs impedance measurements and nothing abnormal was detected at the two separate measurements.The dbs-implants were implanted on the left side of the body: one lead (head), one extension cable (neck, behind the left ear) and one ins (single channel neurostimulator) under the clavicula on upper chest.The patient was fully awake during the surgery, with just local anesthesia.After 5 minutes the patient did feel okay and normal again.No burned skin was detected around the dbs-battery pocket, along the dbs-extension cable on the neck and head, the dbs-lead at the head or around the patient return electrode pad.The patient didn´t feel any pain or heat during the massive contraction or afterwards the patient noted that the electrical shock did go in both sides of the body, but the most severe side of the body was right side with muscular contractions in mouth, cheek, fingers and toes, at the right side of the body.

Manufacturer Narrative

Additional review indicated that patient code c50660 is no longer applicable to the event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 10659623
• MDR Text Key: 211001789
• Report Number: 1226420-2020-00121
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169617148
• UDI-Public: 00643169617148
• Combination Product (y/n): N
• PMA/PMN Number: K093695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 0219184614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 90